Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free  Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. This occlusion has the potential to prevent the set from being primed for use and cause a delay in therapy.
Product List Number: 14699-28;   Lot Number: 17-077-NS
Food service establishments in IL, IN, KY, MI, OH  No international
Garlic Pepper,  6 lb plastic gallon,  product number 63964;  Garlic Pepper,  1.5 lb plastic jar,  product number 63945;  Garlic Pepper,  20 lb plastic pail,  Product code 64002
Product labeling does not contain a listing of ingredients.  Undeclared Soybean oil.
All lots manufactured / distributed since 2011
Italian Herb seasoning,  6 lb plastic pail,  product number 64688;  Italian Herb seasoning,  1.5 lb plastic gallon,  product number 64667;  Italian Herb seasoning,  6 oz plastic jar,  product number 64648;  Italian Herb seasoning,  3 lb plastic pail,  product number 64686
Seasoning salt,  30 lb plastic pail,  product number 68429;  Seasoning salt,  8.75 lb plastic gallon,  product number 68391;  Seasoning salt,  2.5 lb plastic jar,  product number 68372;  Seasoning salt,  15 lb plastic pail,  product number 68410
Garden season no salt,  5 lb plastic gallon,  product number 63516;  Garden season no salt,  1.25 lb plastic jar,  product number 63514
Salt Free Vegetable Herb,  5.5 lb plastic gallon,  product number 63524;  Salt Free Vegetable Herb,  1.5 lb plastic jar,  product number 63522
Seafood seasoning,  5 lb plastic gallon,  product number 68296;  Seafood seasoning,  1.25 lb plastic jar,  product number 68277;  Seafood seasoning,  10 lb plastic pail,  product number 68315
Product labeling does not contain a listing of ingredients.
Herb De Provence,  1.25 lb plastic gallon,  product number 64477;  Herb De Provence,  6 oz plastic jar,  product number 64458;  Herb De Provence,  3 lb plastic pail,  Product code 64496
Hickory Smoke salt,  7.5 lb plastic gallon,  product number 64527;  Hickory Smoke salt,  2.25 lb plastic jar,  product number 64553;  Hickory Smoke salt,  15 lb plastic pail,  Product code 64591
Jamaican Jerk seasoning  6.25 lb plastic gallon,  product number 64838;  Jamaican Jerk seasoning,  1.75 lb plastic jar,  product number 64819;  Jamaican Jerk seasoning,  12 lb plastic pail,  product number 64857
Taco seasoning,  5.5 lb plastic gallon,  product number 68667;  Taco seasoning,  1.5 lb plastic jar,  product number 68665
Curry Powder,  4.25 lb plastic gallon,  product number 63375;  Curry Powder,  1 lb plastic jar,  product number 63356
Pumpkin pie spice,  4 lb plastic gallon,  product number 67644;  Pumpkin pie spice,  1 lb plastic jar,  product number 67642
Cajun seasoning,  5.5 lb plastic gallon,  product number 61798;  Cajun seasoning,  1.5 lb plastic jar,  product number 61779;  Cajun seasoning,  12 lb plastic pail,  product number 61817
Fajita seasoning,  9 lb plastic gallon,  product number 63545;  Fajita seasoning,  2.5 lb plastic jar,  product number 63543
BBQ Spice,  6 lb plastic gallon,  product number 61608;  BBQ Spice,  1.75 lb plastic jar,  product number 61589;  BBQ Spice,  15 lb plastic pail,  product number 61627
Bayside Seasoning,  2 lb plastic jar,  product number 61497
Lemon Pepper,  5 lb plastic gallon,  product number 65085;  Lemon Pepper,  1.25 lb plastic jar,  product number 65066;  Lemon Pepper,  12 lb plastic pail,  product number 65104
Blackened seasoning,  5.5 lb plastic gallon,  product number 61703;  Blackened seasoning,  1.5 lb plastic jar,  product number 61684;  Blackened seasoning,  10 lb plastic pail,  product number 61722
Onion salt,  9 lb plastic gallon,  product number 65845;  Onion salt,  2.5 lb plastic jar,  product number 65826;  Onion salt,  20 lb plastic pail,  product number 65864
Quebec Steak seasoning,  1.5 lb plastic jar,  product number 67783;  Quebec Steak seasoning,  6 lb plastic gallon,  product number 67802;  Quebec Steak seasoning,  10 lb plastic pail,  product number 67821
Chili Powder,  5 lb plastic gallon,  product number 62235;  Chili Powder,  1.25 lb plastic jar,  product number 62216;  Chili Powder,  10 lb plastic pail,  product number 62254;  Chili Powder,  22 lb plastic pail,  product number 62273
Celery salt,  8 lb plastic gallon,  product number 62064;  Celery salt,  2 lb plastic jar,  product number 62045;  Celery salt,  16 lb plastic pail,  product number 62083
Quebec Chicken seasoning,  1.25 lb plastic jar,  product number 67688;  Quebec Chicken seasoning,  5 lb plastic gallon,  product number 67707;  Quebec Chicken seasoning,  10 lb plastic pail,  product number 67726
Garlic Salt,  9 lb plastic gallon,  product number 64078;  Garlic Salt,  2.5 lb plastic jar,  product number 64059;  Garlic Salt,  20 lb plastic pail,  Product code 64097;  Garlic Salt,  34 lb plastic pail,  Product code 64116
Cartridge  The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
The intraocular lens could become lodged within the cartridge
Alcon Monarch II C Cartridge Model 8065977762, Lot Number 32395407, Manufacture Date 8/13/2015
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Koi Palace Mini Moon Cake: Mini Fresh Five Nuts with Smoked Ham  Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. This product has undeclared wheat, walnuts, and pine nuts.
Koi Palace Mini Moon Cake: Luxury Single Mooncake - Mini Fresh Five Nuts with Smoked Ham  Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredients include wheat,  walnut, pine nut, sesame street, egg yolk.
Koi Palace Mini Moon Cake: Single Box - Mini Pumpkin Seed Paste  Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredients include wheat, peanut oil, pumpkin seed.
Koi Palace Mini Moon Cake: 8 Mini Treasures Combo  Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredients include WHEAT, GLUTEN, EGGS, MILK, PEANUTS, PINE NUTS, ALMONDS, WALNUTS, SESAME.
Koi Palace Mini Moon Cake: Mini Egg Yolk in White Lotus Seed Paste:  Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. This product has undeclared peanut oil,  wheat and egg.
Koi Palace Mini Moon Cake: Seven Stars Reunion  Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredients for this product are WHEAT, GLUTEN, EGGS, MILK, PEANUTS, PINE NUTS, ALMONDS, WALNUTS, SESAME.
Koi Palace Mini Moon Cake: Five Nuts with Smoked Ham & Egg Yolk  Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. This product has undeclared wheat, walnuts, pine nuts.
Koi Palace Mini Moon Cake: Luxury Single Mooncake - Mini Fresh Jasmine Paste. Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredients include wheat,  peanut oil.
Koi Palace Mini Moon Cake: Luxury Single Mooncake - Mini White Lotus Seed Paste w/ Egg Yolk  Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredients include wheat, peanut oil, egg yolk.
Koi Palace Mini Moon Cake: Single Box - Mini Oolong Tea Paste  Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredients include wheat, peanut oil.
Koi Palace Mini Moon Cake: Luxury Single Mooncake - Mini Bird's Nest, Black Sesame & Coconut Paste  Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredients include wheat, peanut oil, coconut..
Koi Palace Mini Moon Cake: Single Box - Mini Rose Paste  Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredients include wheat flour and peanut oil.
Koi Palace Mini Moon Cake: Luxury Single Mooncake - Mini Black Truffles with Five Nuts. Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredients include wheat, walnut, pine nuts, pumpkin seeds and sesame street.
Koi Palace Mini Moon Cake: Single Box - Mini Walnut, Red Bean Paste  Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredient include wheat, peanut oil, and walnuts.
Koi Palace Mini Moon Cake: Dalmaji with Happy Family  Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredients include  WHEAT, GLUTEN, EGGS, MILK, PEANUTS, PINE NUTS, ALMONDS, WALNUTS, SESAME
Koi Palace Mini Moon Cake: Luxury Single Mooncake - Mini Wolfberry & Dates Paste. Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredients include wheat.
Worldwide Distribution-US: (Nationwide) and countries of: Saudi Arabia, Germany, Austria, Belgium, Estonia, Poland, Switzerland, Canada, Luxembourg, Netherlands, Bulgaria, Malaysia, Italy, Ireland, Great Britain, France, Brazil, Sweden, Slovenia, and Portugal.
ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
This product has been distributed domestically and internationally .
IBF Peanut Butter, Net Weight 450 lbs, Hampton Farms, Severen, NC 27877.
Product was found to contain high levels of aflatoxin.
Alabama, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, and Virginia
BLUE BELL(R) ICE CREAM Chocolate Chip Cookie Dough, Half Gallon, Pint, and 3 Gallon sizes.
All ice cream products, Chocolate Chip Cookie Dough, Cookie Two Step ice Cream, Krazy Kookie Dough, and Blue Monster, containing cookie dough supplied by Aspen Hills, Inc., due to the potential for them to contain Listeria monocytogenes.
BLUE BELL(R) ICE CREAM Blue Monster, 3 Gallons
BLUE BELL(R) ICE CREAM Cookie Two Step, Half Gallon and Pint sizes
BLUE BELL(R) ICE CREAM Krazy Kookie Dough, 3 Gallons
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
1) Lot # B08493 - Expiration Date 12/2016; 2) Lot # B13230 - Expiration Date 08/2018
Distributed to TN, WI, PA, MO, NE, OR, CA, GA and PR.
Sentinel (milbemycin oxime/lufenuron) flavor tabs 5.75 mg milbemycin oxime/115 mg lufenuron
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc, Miami, FL 33186,  NDC 68968-5552-3
Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.
HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20
Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04
US:   Alabama, Alaska, Arizona,Arkansas, California,Colorado,Connecticut,Delaware,  District of Columbia, Georgia,Hawaii, Idaho, Illinois,Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland,Massachusetts, Michigan, Minnesota,   Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Florida, Tennessee, Wyoming.    OUS:  Czech Republic  Algeria  Belgium  Brazil  Canada  Denmark  France  Germany  Greece  India  Israel  Italy  Korea, Republic of  Luxembourg  Netherlands  Poland  Russian Federation  Singapore  United Kingdom
Merge Eye Station  f/k/a: DFC-1024 & DFC-512 Digital Imaging System,  WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS).  Versions: 11.6.0 and prior
This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.
Merge Eye Station software versions: 11.6.0 and prior
Worldwide Distribution - USA (nationwide) Distribution  including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, China, Colombia, Costa Rica, Dubai, Denmark, Germany, Finland, France, Great Britain, Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Mexico, Malaysia, Netherlands, Norway, Poland, Portugal, Puerto Rico, South Africa, Sweden, Singapore, Switzerland, Thailand, Turkey and Venezuela.
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
The firm received complaints of cracks in the weld on the head of the mallet.  In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.
Thru out the US and three foreign countries.
Sabra Spreads Honey Mustard, 8.5OZ; UPC 040822343121; SKU301587
Products have the potential to be contaminated with Listeria monocytogenes.
Best Before dates on or before January 23, 2017
Sabra Hummus w/Supremely Spicy, 7 OZ, 10 OZ, 17 OZ    UPC                      SKU                   ITEM    040822011433     300158               Sabra Hummus Supremely Spicy  7OZ    040822011440     300159               Sabra Hummus Supremely Spicy  10OZ    040822017558     300161               Sabra  Hummus Supremely Spicy  17OZ
Sabra Hummus Jalapeno, 10OZ UPC 040822011921, SKU 300106
Sabra Hummus Caramelized Onion, 10 OZ, UPC 40822014700, SKU 300051
Sabra Hummus Lemon, 10OZ; UPC 040822011648; SKU     301483
Sabra Hummus Taco, 10OZ; UPC 040822343671; SKU 301640
Sabra Hummus Classic, 7 OZ, 10 OZ, 17 OZ, 30 OZ, 5 LB, 2 OZ, 4.56 OZ;     UPC                           SKU           ITEM    040822000017          300066      Sabra Hummus Classic 7OZ                                           040822011143          300067      Sabra Hummus Classic 10OZ                                        040822017497          300070      Sabra Hummus Classic 17OZ                                        040822014687          300074      Sabra Hummus Classic 30OZ                                        040822431156          300076      Sabra Hummus Classic 5LB                                              040822011112          300079      Sabra Hummus Classic 2OZ                                             040822011952          300080      Sabra Hummus Classic 4.56OZ                                     040822342728          301481      Sabra Hummus  Classic  2OZ    040822017497          301290      Sabra  Hummus  Classic  17OZ    040822010078          301511      Sabra  Hummus  Classic  2OZ    040822010047          301512      Sabra  Hummus  Classic  2 OZ
Sabra Hummus Bold & Spicy, 4.56OZ; UPC 040822342506; SKU301430
Sabra Spreads Garlic Herb, 8.5OZ; UPC 040822343138, SKU301586
Sabra Hummus Garlic, 7 OZ, 10 OZ, 17 OZ, 32 OZ, 30 OZ, 4.56 OZ, 23.5 OZ,    UPC                      SKU                   ITEM    040822011235      300094              Sabra Hummus Garlic  7OZ    040822011242      300095              Sabra  Hummus Garlic  10OZ    040822017510      300097              Sabra  Hummus Garlic  17OZ    040822012256      300099              Sabra  Hummus Garlic  32OZ    040822301121      300100              Sabra  Hummus  Garlic  30OZ    040822011990      300104              Sabra  Hummus  Garlic  4.56OZ    040822017510      301480              Sabra   Hummus  Garlic  17OZ
Sabra Hummus 3 Pepper Chili, 10OZ; UPC 040822344043; SKU301705
Sabra Hummus SF Rosemary/Sea Salt, 10OZ; UPC 040822342988, SKU 301566
Sabra Hummus Red Pepper, 2 OZ, 4.56 OZ, 5 LB, 7 OZ, 10 OZ, 17 OZ, 30 OZ, 32 OZ    UPC                      SKU                   ITEM  040822012430     300142              Sabra Hummus Red Pepper 7OZ    040822011549     300143              Sabra Hummus Red Pepper 10OZ    040822017503     300146              Sabra Hummus Red Pepper 17OZ    040822328647     300148              Sabra Hummus Red Pepper 32OZ    040822301114     300150              Sabra Hummus Red Pepper 30OZ    040822434553     300151              Sabra Hummus Red Pepper 5 LB    040822011969     300153              Sabra Hummus Red Pepper 4.56 OZ    040822017503     300502              Sabra Hummus Red Pepper 17 OZ
Sabra Hummus Sun Dried Tomato, 10OZ    UPC                      SKU                   ITEM    040822014731     300166	Sabra Hummus Sun Dried Tomato 10OZ
Sabra Hummus Olive, 10OZ; UPC 040822011341; SKU 300117
Sabra Hummus Spinach/Art, 10 OZ, 17 OZ, 32OZ    UPC                      SKU                   ITEM  040822027700          300266      Sabra Hummus Spinach/Art 32OZ                              040822027588          300298      Sabra Hummus Spinach/Art 17OZ                              040822027540          300164      Sabra Hummus Spinach/Art   10OZ
Sabra Hummus Pine Nut, 7 OZ, 10 OZ, 17 OZ, 32 OZ    UPC                      SKU                   ITEM    040822011747    300132               Sabra Hummus Pine Nut 10OZ    040822127530    300134               Sabra Hummus Pine Nut 7OZ    040822990011    300136               Sabra Hummus Pine Nut 17OZ    040822012157    300139               Sabra Hummus Pine Nut 32OZ    040822990011    300501               Sabra Hummus Pine Nut 17OZ
Sabra Spreads Spicy Chili, 8.5OZ; UPC 040822343145, SKU 301585
Sabra Hummus Tuscan Herb Garden, 17OZ, 32 OZ    UPC                      SKU                   ITEM  040822330381      301485              Sabra Hummus Tuscan Herb Garden 17OZ    040822330466      300736              Sabra Hummus Tuscan Herb Garden 32OZ
Nationwide Distribution to FL, IA, NH, PA, SC and TX
VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restorative, core build-up or luting materials. It can be applied with phosphoric acid etching (selective enamel etching or total-etch) of the dental hard tissue as well as without (self-etch). A1] Adhesive for direct restorations of all classes of cavities using light-curing composite /compomer / Ormocer materials with a methacrylate base. [A2] Adhesive for core build-ups made of light-curing composite materials. [A3] Adhesive for indirect restorations with light-curing luting composites. [B] Intraoral repair of composite, compomer or Ormocer restorations, ceramic veneers and allceramic restorations without an additional primer. [C] Treatment of hypersensitive tooth necks. [D] Protective varnish for glass ionomer cement restorations. [E1] Sealing of cavities prior to amalgam restorations. [E2] Sealing of cavities and core preparations prior to the temporary luting of indirect restorations. In combination with Futurabond M+ DCA (Dual Cure Activator): [F1] Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups.
Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.
Fabi-saa Melcochas Candy Net Wt. 8 oz. Fabi-Saa Inc. 39 Montgomery Street Belleville, NJ 07936 UPC 181683000676
NYSDAM analysis revealed the presence of yellow #5 in Melcochas Candy.
all codes   distributed from March 7 2016 - October 27 2016
All lots (product is seasonal: September-November)
US Distribution to the states of : MD, TX, and WI.  There was no foreign/military/government distribution.
Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241.
Product malfunction: Needle does not retract.
10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only,  Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06
Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
Worldwide Distribution: US (Nationwide) and countries of: Canada, China, Chile, Mexico, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria, Peru, Colombia, Ecuador, Bolivia, Costa Rica, Honduras, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Algeria, Greece, Guatemala, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Netherlands, Norway, Pakistan, Panama, Paraguay, Poland, Portugal, Republic Korea, Romania, Russian Fed., Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Jordan, U.A.E., United Kingdom and Uruguay.
SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone)     Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK    For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma and serum, as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
2728 kits (US: 565 kits; OUS: 2163 kits)
Implant Direct Sybron Manufacturing, LLC
U.S. distribution to the following; WA.    Foreign distribution to the following; Netherlands.
GoDirect Screw-Retaining Top  Part Numbers: 4500-61
Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Worldwide Distribution - US including NJ, NC, TX, IL, VA, NY, FL, CA, MS, WA, IN, and MA. and Internationally to Canada and Costa Rica.
Natus Warmette Blanket Cabinet and Warmette Dual Cabinet  The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items
The fuse blows during initial power up or after a period of time.  This results in a complete loss of power to the Cabinet and in some cases has resulted in the fuse cover for the power inlet melting slightly.
Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.
Ceres-C Standalone Cervical Interbody    The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.
Part Number 08-170-1010 - Lot Number 134926; Part Number 08-170-1011 - Lot Number 134927;  Part Number 08-170-1006 - Lot Number 134929; Part Number 08-170-1008 - Lot Number 134931
Reunion TSA Peg Alignment Sound   Catalog #5901-1038  The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to final implantation into the glenoid vault. Its purpose is to provide assurance that the drilled holes for seating of the Glenoid implant have been properly prepared using the provided instrumentation
Reunion TSA Peg Alignment Sound broke during surgery.
Nationwide to FL, CA, UT, AZ, MN, IL, CO, NM , OH, MO, ID. Canadian consignees. No other foreign or VA/govt/military consignees.
Condor Snacks Sour Cream & Onion W/O MSG. Product Code: T3235. 50 lb bags
Products have been recalled due to potential for Salmonella contamination.
White Cheddar Jalapeno Snack Seasoning / Barrel O' Fun. Product Code: T3840. 50 lb bags
Ranch Dressing / Hires Big H. Product Code: T3642. 500/14g pouch
FH White Cheddar 2410. Product Code: T206209-50. 50 lb bags
Super Nacho (No-Pho, Gluten Free). Product Code: T4034. 50 lb bags.
Nacho Snack Seasoning / Harvest Pride /Tom Smith. Product Code: T3809. 50 lb bags
Super Otirod. Product Code: T3188. 50 lb bags
Xtra Sharp Cheese Sauce. Product Code: T4015. 37.5 lb bags
Jalapeno Popper Snack Seasoning / Shearer's Foods LLC. Product Code: T3873. 50 lb bags
Habanero Ranch Seasoning / Shearer's. Product Code: T4053. 50 lb bags
Non-GMO Sour Cream & Onion / Deep River Snacks. Product Code: T3527. 50 lb bags
Chipotle Ranch ASI. Product Code: T3883. 33 lb bags
Cheese Puff Seasoning / Kay's Naturals. Product Code: T3852. 50 lb bags
Chedder and Sour Cream ASI. Product Code: T3937. 33 lb bags
Triple Cheese Blend - No Color. Product Code: T4008. 50 lb bags
Ranch Seasoning / Letnes/Grizzly's Grill. Product Code: T3576. 10 lb bags
French Onion Seasoning ASI. Product Code: T3933. 33 lb bags
Broccoli Cheese Soup /  Comfort Foods. Product Code: T3872. 50 lb bags
Guy's Sour Cream & Cheddar Chip Seasoning. Product Code: T3040A. 50 lb box
OC Ranch French Fry Seasoning/CraftWorks. Product Code: T3996. 12 lb bags
FH Parmesan. Product Code: T206486-50. 50 lb bags
Biscuits & Gravy Seasoning CR/ Barrel O' Fun. Product Code: T3669. 50 lb bags
Jalapeno Popper ASI. Product Code: T3934. 33 lb bags
Four Cheese Sauce Mix CR. Product Code: T1729-200. 200/1 lb drums
Buttermilk Ranch Snack Seasoning / Meat Chips. Product Code: T3760. 50 lb box
Spicy Nacho. Product Code: T3552. 50 lb bags
ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.
N-C Butter Flavor Nat WONF, NET WEIGHT: 50 LBS, FONA International, Inc., 1900 Averill road, Geneva, IL 60134
Possible contamination of product with Salmonella.
Vanilla Type Flavor, Nat & Art, NET WEIGHT: 22.68 KGS, FONA International, Inc., 1900 Averill road, Geneva, IL 60134
N-C Butter Flv Nat & Art , NET WEIGHT 50 LBS, FONA International, Inc., 1900 Averill road, Geneva, IL 60134
Nat Cream Flavor Powder (WONF), NET WEIGHT 50 LBS, FONA International, Inc., 1900 Averill road, Geneva, IL 60134
N-C Chai Tea Flavor, Nat & Art, NET WEIGHT: 50 LBS, FONA International, Inc., 1900 Averill road, Geneva, IL 60134
Domestic: None    Froeign: Netherlands & Switzerland    VA/DOD: None
Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier. The pouch is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The pouch and carton labels also contain sterilization indicator dots.  Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement. The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement
Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Date of Mfg. 26 Apr 2015
Product was shipped to the following states: AL, AR, AZ, CA, CO, DE, FL, GA, IA, IN, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
The firm was notified by one of their ingredient suppliers that their facility and finished product test positive for Salmonella.
Copperleaf Kitchen, LLC Comfort Foods Division
Nationwide to AZ, CO, TX and WI. No Canadian, other foreign, VA/govt/military consignees.
Country Gardens Cuisine, Singles, Broccoli Cheese Soup with Rice, Net Wt. 1.25 oz (35 grams)
Recalling Broccoli Cheese Soup with Rice after supplier  received notice of voluntary recall of positive environmental tests for Salmonella.
Batch: 788227316  Lot: BCS788227316  Product number: 09500  Expiration date: Sep2018
Detailed product distribution on the Attachment.  Please note the firm distributed product to 8 Brokers and 3 Direct Accounts.  The following States are were product was distributed to various Brokers and Direct Accounts. NE, MI, NY, TN, NJ TX, SC, MA, PA and MD
Non Fat Dry Milk, Grade A - High Heat in 50 # bags , manufactured by Valley Milk Products. Stasburg, Virginia 22657 , Permit No. 51-4136  Net Weight - 50 LBS
Products are recalled due to potential Salmonella contamination.
Sweet Cream Buttermilk Powder in 50 # bags , manufactured by Valley Milk Products. Stasburg, Virginia 22657  Plant No. 519410  Net Weight - 50 LBS
Cardboard sleeve: Cheese Club express mac Macaroni & Cheese Dinner, Four  2.05 OZ Bowls; Net Wt. 8.2 OZ.; Distributed by: Aldi, Inc., Batavia, IL 60510
Fourth Street Barbecue Inc./ Packing Division has initiated the voluntary recall of Cheese Club Express Mac & Cheese 4 cup dinner and Double Takes Macaroni & Cheese 2 cup dinner due to possible health risk. The powdered cheese packets may be impacted by milk powder ingredients recalled by Valley Milk Products, LLC contaminated with Salmonella.
Cardboard sleeve: Double Takes Macaroni & Cheese Dinner, Distributed By: Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320; Double Takes: Best By: 10/11/17 10/12/17 10/13/17 10/19/17 10/20/17 10/24/17 11/28/17 11/29/17 11/30/17;  UPC: 63927701208:
Algerbrush-II    Product Usage:  Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
2487 units Domestic (USA), 1,211 units Foreign (outside USA)
According to firm ( Bausch & Lomb, Inc. )  on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond).   Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction. Therefore Bausch & Lomb is proposing a Field Correction to provide customer purchasing product from April 30, 2012 to June 20, 2016 with the current operating instruction.
LOT #(s) AND EXPIRATION DATES, SERIAL #(s), ORDER #, or OTHER IDENTIFICATION #(s):    SKU E0815 A, SKU E0815 B, SKU E0815 0.5, SKU E0815 1.0 and SKU E0816 C
United Food Ingredients, Inc. Ranch Seasoning Complete, NET WT. 50 lbs., 15W700 South Frontage Road, Burr Ridge, IL 60527
Firm is recalling Ranch Seasoning due to the potential for Salmonella contamination.
United Food Ingredients, Inc. Blue Cheese Snack Seasoning, NET WT. 50.0 lbs., 15W700 South Frontage Road, Burr Ridge, IL 60527
Firm is recalling Blue Cheese Seasoning due to the potential for Salmonella contamination.
US and worldwide: Kuwait, Dubai, United Kingdom, Israel, Australia, Mexico, Dominican Republic, Sweden, Colombia, Canada, Brazil, Panama, Netherlands, Norway, Philippines, Saudi Arabia, Peru, Singapore, Korea, Russia,
4 oz. Complete Cookie, Coconut Chocolate Chip, UPC Code: 7 87692-83538 6,   12pks: 15,834 sleeves (contains 12 cookies)   Total cookies from pack sizes above: 190,008
Lenny & Larrys is recalling Chocolate Chip and Coconut Chocolate Chip cookies due to the possible presence of undeclared milk in the dark chocolate chips.
4 oz. Complete Cookie, Chocolate Chip, UPC Code: 7 87692-83461 7,   12pks: 231,114 sleeves (contains 12 cookies)  6pks: 54,660 sleeves (contains 6 cookies)   4pks: 795,528 sleeves (contains 4)   Total cookies from all pack sizes above: 6,283,440
New York, Pennsylvania and the Connecticut
NEW HOPE MILLS Crepe MIX, NET WT. 1 LB. 4 OZ, UPC 074703601529 --- 181 York Street, Auburn, New York 13021 ---Product is packaged in a brown paper bag
The lots of Crepe Mix were produced from a lot received which is being recalled by the bulk milk powder manufacturer as it has the potential to be contaminated with Salmonella.
BEST BY: 07/19/17:A1; EXPANSION: BEST BY: 09/15/17:A1 (Codes can be found on the back of the flap)
HEB Homestyle White Corn Tortillas, 12 Count and 30 Count packaged in clear plastic bags.
Foreign material, possibly corn husk, present in corn tortillas.
UPC codes: 4122058841 and 4122058742; Best by dates Dec 17 and Dec 18, 2016
Florida, Virginia, Maryland, Delaware, New Jersey, New York, Connecticut, and Massachusetts
Linden's brand Chocolate Chip Cookies:  a) Chocolate Chippers Bite Size Cookies (Mini), NET WT. 2 OZ., UPC 76809-30017; b) Chocolate Chippers (Mini), NET WT 1.1 OZ., UPC 76809-30090; c) 3 LARGE CHOCOLATE CHIP COOKIES (Pack), NET WT. 1.75 OZ. UPC 76809-30010 --- LINDEN COOKIES, INC. 25 BRENNER DRIVE CONGERS, NY 10920
The product contains undeclared milk from the bulk chocolate chips received from the supplier.
a): Sell By Dates Feb. 8, 2017 through March 28, 2017;  b): Sell By Dates Feb. 8, 2017 through March 28, 2017;  c): Dec. 14, 2016 through Feb 01, 2017
U.S. distribution to the following: MI, TX, TN, IN, AL, FL, PA, AK, WI, MT, SC, CO, CA, NH, NC, NJ, DE, AZ, MN, MS, GA, DC, IA, NY, NM, KS, OH, OK, SD, OR, NV, VA, MD, WA, CT    Foreign distribution to the following: CA.
Reprocessed Electrophysiology Catheter Cables  Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT    Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables either interface an EP catheter with the appropriate external stimulation or recording equipment or, serve as an extension cable between an EP catheter and equipment out of immediate reach
A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
All lots with the following Expiration Date Scope: Between 3/1/2018 and 10/31/2018 (Also displayed as Mar-2018 to Oct-2018)
Reprocessed Ablation Catheter Cable  Catalog Number: CR3425CT, CR3434CT    Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an ablation catheter and a multi-pin connector on the proximal end which connects to the appropriate equipment. The cables either interface an ablation catheter with the appropriate external radiofrequency generator or, serve as an extension cable between an ablation catheter and equipment out of immediate reach.
Medtronic Inc., Cardiac Rhythm and Heart Failure
US:  All states in USA including DC & PR.       OUS:     Australia, Finland, Japan, Saudi Arabia, Austria, 	France, Korea,Singapore,  Bangladesh, Germany,	Luxembourg, South Africa, Belgium,	Greece, Malaysia, Spain, Brunei Darussalam, Guadeloupe, Netherlands, Sweden, Cayman Islands, Hong Kong,	New Zealand, Switzerland, Chile, India, Norway, Thailand, Cyprus, Iran, Poland, Turkey, Denmark,  Ireland, Portugal,	 United Arab Emirates,  Dominican Republic, Italy, Reunion,	United Kingdom.
Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.
During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices may appear to be enabled when it is not active.
Chocolate Holdings Inc. DBA Charles Chocolates
San Francisco, Alameda and San Mateo CA only.
Charles Chocolates Toffee Chocolate Macadamia;  NET WT. 6.2 oz .(180 grams)    UPC: 8 59033 00440 6    Charles Chocolates, San Francisco, CA
Charles Chocolates received a consumer complaint that theToffee Chocolate Macadamia product contained hazelnuts instead.
Grab & Go Chicken Salad on Croissant Packed by World Food LLC Orlando FL 32837 Net WT 8oz
Chicken Salad on Croissant has potential to be undercooked.
Worldwide Distribution - US Nationwide in the states of AL, FL, GA, IA, IL, IN LA, MI, PA, TX, WI, and the country of Canada
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile.  2 FL OZ (59 ml).    Product Usage:  For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company.
Lot Numbers: 6I26; Unit No: MDS032285; Expiration Date: 08/2019
US Distribution to the states of : CA, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, NE, NV, NJ, NM, NY, OR, SC, TN, TX, UT, VA, WA
SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
The product contained a latex catheter instead of a silicone catheter.
Plasma products, for which a failure to quarantine units due to medical history occurred, were distributed.
Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated
RBC unit, incorrectly labeled as irradiated, was distributed.
Blood products, collected from donors for whom eligibility was inadequately determined, were distributed.
AL, MS, AR, MO, LA, TN, GA, NC, SC, FL, TX,
Tropical Fruit Supreme, packaged under the following brands: (a) St. Clair, product code 104001, ST. CLAIR FOODS, INC., NET WT. 5 LBS (2.27 kg), MEMPHIS, TN 38116, UPC 7717114001  (b) Classic SYSCO(R), product code 1527001, NET WT. 5 LBS (2.27 kg), DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TX, 77077-2099, UPC 7486510135  (c) Golden Harvest(TM), product code 920401, NET WT. 5 LBS(2.27 kg), Distributed by Ben E. Keith Foods, Fort Worth, TX  76140, UPC 4604502229  (d) Ron's Home Style Foods, product code 900601, NET WT. 5 LBS(2.27 kg), DIST. BY RON'S HOME STYLE FOODS, INC., HOUSTON, TX 77021, UPC 9693884202
Firm recalled three fruit salad products which were manufactured using Valley Milk Dry Milk which is currently being recalled due to the potential for salmonella contamination.
Pineapple Nut Delight, packaged under the following brands: (a) St. Clair, product code 104003, ST. CLAIR FOODS, INC., NET WT. 5 LBS (2.27 kg), MEMPHIS, TN 38116, UPC 7717114003  (b) Classic SYSCO(R), product code 7166358,  NET WT. 5 LBS(2.27 kg), DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TX  77277-2099, UPC 7486544463  (c) Ron's Home Style Foods, product code 900603, NET WT. 5 LBS(2.27 kg), DIST. BY RON'S HOME STYLE FOODS, INC., HOUSTON, TX 77021, UPC 9693883202
Pistachio Cream, packaged under the following brands: (a) St. Clair, product code 104004, ST. CLAIR FOODS, INC., NET WT. 5 LBS (2.27 kg), MEMPHIS, TN 38116, UPC 7717114004  (b) Ron's Home Style Foods, product code 900603, NET WT. 5 LBS(2.27 kg), DIST. BY RON'S HOME STYLE FOODS, INC., HOUSTON, TX 77021, UPC 9693883202
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Drills cannot be inserted into handpiece due to  tolerance specification not met
Nationwide and one retail  location in British Columbia, Canada
Williams-Sonoma Meyer Lemon Poppy Quick bread mix, NET WT. 1 LB. 2 OZ (509 g)
1220 units, 972 units currently at retail outlets
Williams Sonoma was notified by their contract manufacturer that high heat non fat dry milk powder that is now under recall for Salmonella was used in production of one of their quick bread mixes.
US Nationwide distribution in the following states: AL, CA, FL, GA, HI, IL, IN, KS, LA, MA, MI, MS, NJ, NY, OH, PA, SC, VA, WI, WV, & WY.
FV-RF (Clinix RF Plus)    Product Usage:  A Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical regions. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
There's a potential for liquid penetration into the back side of the front control panel of the X-ray diagnostic table, which can cause a short circuit of the terminals of the tilt operation and cause an unintentional tilt of the table.
Starkey Spring Water, Item code STC.5, 16.9 FL oz.  (500 mL) glass bottle.  Product UPC 8 11904 02000 7.  Case UPC 8 11904 02002 1.
Starkey Spring Water, 16.9 fl oz. glass bottles, are recalled because 11.7 ppb of arsenic was detected in water sample.
Worldwide Distribution - US Nationwide in the states of CA, CO, GL, GA, HI, IL, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, PA, TN, TX, UT, WA. .
Artis Q/Q.zen,  Angiographic x-ray system  Stand alone system  The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following:  - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator.  - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
Artis zee/zeego, Angiographic x-ray system  Stand alone system  The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
US Distribution to the states of : NJ, TN. OR and FL.
Eclipse Treatment Planning System version 13.MR2 [13.06.31  with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12]      Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients  with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron  and proton beams, as well as for internal irradiation (brachytherapy) treatments.
Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain conditions are fulfilled.
The one system was distributed in Canada.      There were no government or US distribution.
Brilliance iCT    Product  Usage:  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
Failure to correctly document the installation of four M12 Bolts into the system rotor.
Model Number 728306; System Serial Number 100619  Rorot-45535-673-94382 SN26
ALN UNICED 1/4 Sheet Split Layer White Cake, Item 00886, three stacked cake layers with plastic liner in between layers are packaged in a corrugated box, a total of 12 cakes per bulk box. UPC 00750903008862
-MFG Date 6237, Manufacture Date: 08-24-2016.  -MFG Date 6285, Manufacture Date: 10-11-2016.  -MFG Date 6286, Manufacture Date: 10-12-2016.
Worldwide Distribution - US Nationwide in the states of AR, IN, LA, MA, MN, OR, TN & TX. and the countries:  Australia, Belgium, Denmark, France, Germany, Israel, Japan, Republic of Korea, Poland, Portugal, Slovenia, Switzerland, Thailand and United Kingdom.
IQon Spectral CT with software version 4.7.0    Product Usage:  The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. The IQon Spectral CT system acquires one CT dataset composed of data from a higher-energy detected x-ray spectrum and a lower-energy detected x-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results.
Worldwide Distribution - US Nationwide in the state of CA, IN, KY, MA, NJ, NY, NC, PA, TX, WI, and the countries of Brazil, Canada, China, Croatia, Estonia, Germany, India, Japan, Netherlands, New Zealand, Norway, Poland, Serbia, South Africa, Spain, Russia, Turkey
Monaco RTP System    Product Usage:  Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O  The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
Worldwide Distribution - US including U.S. States: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS,  NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PUERTO RICO, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada, Mexico, and Costa Rica
OEC 9800. MDL Numbers: D222250, D141598  The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.
OEC MiniView 6800. MDL Number: D002533  The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging
The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretionOEC 9900 Elite. MDL Numbers: D148942, D155043
Po Folks Cornbread Mix, Net Wt., 5 lb bags, UPC Code 0 73484 22509 2
Product contains milk product from a supplier that is recalling product due to the possible presence of Salmonella.
House-Autry Butterflake Biscuit Mix, Net Wt. 25 lb. bags, UPC Code 0 73484 20513 1,
Roy Roger's Pancake Mix, Net Wt., 2 lb. 8 oz. bags, UPC Code 0 73484 22724 0
House-Autry Cheese Biscuit Mix, Net Wt., 8 oz. (227 g.), UPC Code 0 73484 15510 8,
House-Autry Buttermilk Biscuit Mix Tote, Net Wt., 8 oz. (227 g.), UPC Code 0 73484 15500 9,
House Autry, stone Ground Buttermilk Corn Bread Mix, Net wt. 8 oz. boxes, UPC Code 0 73484 15512 2,
Buddy's Bar-B-Q Hushpuppy Mix, Net Wt., 5 lb bags, UPC Code 0 73484 22156 2,
Worldwide Distribution -  USA (nationwide) Distribution  including Puerto Rico and to the countries of : Australia, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, France, Germany, Gibraltar, Ecuador Hong Kong, India, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, New Zealand, Oman, Panama, Philippines, Poland, Portugal,  Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.
UniCel DxH 800 Coulter Cellular Analysis System,  Catalog No. 629029, B24465, B24802, B68304
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as sample limitations.
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
This voluntary recall is limited only to the Sour Cream & Chive Flavor, distributed to retail, grocery, and food service in the USA, Hong Kong, Jakarta, and Singapore.
2 oz Sour Cream & Chive cases:  6,207 , 6 oz Sour Cream & Chive cases:  2,402
On December 19th, Small Fry Inc. was advised by their seasoning supplier that an ingredient in the Sour Cream & Chive seasoning was subject to a RECALL.  The ingredient is nonfat dry milk powder, and was produced by their supplier.  An FDA inspection identified Salmonella at the supplier's facility.
Kalare DREX-KL80, Model No. KXO-80XD  Diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations
It has been found that the generator of the system could possibly terminate the exposure prematurely during an examination. This issue was identified due to a software problem residing in the generator firmware.
Ultimax DREX-ULT80, Model No. KXO-80XM  Multipurpose digital x-ray system for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy
AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.
the Peanut Principle, Dashing Thru the Dough, Gourmet Chocolate Chip Cookie Dough Peanut Butter, NET WT 16oz, UPC 609207898788
Blood product, collected from a donor who travelled to a malarial endemic area within one year of donation, was distributed.
Worldwide Distribution - US Nationwide in the states of AL, CA, DC, NE, NY, ND, OR, PA, RI, SC, TX, and the countries of Angola, Argentina, Armenia, Australia, Austria, Barbados, Belarus, Brazil, Bulgaria, Canada, China Columbia, Curacao, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Kenya, Malaysia, Netherlands, Norway, Oman, Peru, Poland, Portugal, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Yemen, Zambia.
Oncentra External Beam Oncentra Brachy    Product Usage:  Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System  Device Listing Number E454448
The firm has initiated a product correction due to a bag carousel motor error causing misalignment and resulting in a mislabeling of final IV bag preparations.
Worldwide Distribution - US TN only and Internationally to France and Switzerland
Dimensional non-conformity of the thread on the screw head.
Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN,  CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.
Biograph mCT X-3R, Material Number  10248673  The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Biograph mCT Flow Edge-4R, Material Number  10528955  The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Biograph mCT S(64)-4R, Material Number  10248672  The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Bio mCT-S(40) 3R->4R Upgrade, Material Number  10250743  The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
BIOGRAPH mCT 20 Excel, Material Number  10507786  The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Biograph mCT S(40)-3R, Material Number  10248668  The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Biograph mCT S(64)-3R, Material Number  10248669  The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Biograph mCT X-4R, Material Number  10248670  The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Biograph mCT S(40)-4R, Material Number  10248671  The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Biograph mCT-X w/TrueV Upgrade, Material Number  10250745  The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Biograph mCT Flow 40-4R, Material Number  10529159  The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Kogenate FS Antihemophilic Factor (Recombinant) and Helixate FS, where routine stability testing showed potency declining faster than expected in certain lots, were distributed.