Spaghetti Soup; Annie's Kitchen, 2966 Stumptown Rd, Ronks, PA 17572   16 FL OZ
35 cases, 12 pints/cs; 25 cases 12 Qt/cs
Spaghetti Soup  failed to declare the wheat allergen in the spaghetti ingredient and milk allergen in the butter ingredient.
Vegetable Soup; Annie's Kitchen; 2966 Stumptown Rd, Ronks, PA 17572  16 FL OZ
35 cases - 12 pint/cs; 35 cases- 12 Qt/cs.
Vegetable Soup failed to declare wheat allergen in the noodle ingredient.
Worldwide Distribution -  USA (nationwide) including the states of :  CA, CO, CT, FL, HI, IL, IN, LA, MD, MA,M I, MN, MS. MK. NY, NC,ND, OH, OK, OR, PA, RI, TN, VA, WA and WV., and the countries of  Canada and 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).      Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product.   Merge is recalling product from the field to reduce the risk to patient health.
136 T1700 Capture Stations  46 T5810 Capture Stations
Angiodynamics Inc. (Navilyst Medical Inc.)
AZ, CA, FL, GA, IL, IN, KS, MD, MO, MT, NC, NJ, NV, OH, OR, PA, TN, TX, WI
Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/Product No. MRLCA000, REF/Catalog No. MRLCA000 -- medCOMP, 1499 Delp Drive, Harleysville, PA 19438 --- Description: The Celerity ECG Cable Accessory Pack is comprised of two sterile, single use components: a cable cover and an ECG clip cable (alligator clip).  The cable cover is used to sleeve the remote control cable component of the Celerity System so that the user can remotely control the monitor within the sterile field.  The stereo jack end of the remote control cable pierces the sterile cable cover and interfaces with the stereo jack connector end of the ECG clip cable.  The alligator clip side of the ECG clip cable is clamped to the stylet or guidewire to provide the intravascular cavity ECG reading.
The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured.  The affected product is not soldered per specification, and may result in the device not properly conducting the ECG signal.
AngioDynamics UPN H787471431 Batch/Lot Numbers: 5015180, MBVR240D, MBVT150R, MBVT210D, MBVT220D, MBVT240D, MBVT250D, MBVT680D, MBVT700D, MBVX090D;  medCOMP UPN MRLCA000, Batch/Lot Number MBVT240.
Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A.  The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The design of the actuator component of REF 1543A has been enhanced by the addition of a linear gear designed to increment the dose-counter on some pMDI canisters. REF 1543A provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs the medication through the dual orifices into the airstream
The insert and case label description of the device incorrectly reads Counter Incrementing Actuator with 22mm O.D./I.D. Connections.
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
HOTLINE Blood and Fluid Warmer, Mole l HL-90.  Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Domestic: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA WI, & WV.
Potassium Chloride Oral Solution,  USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL  33771.
Defective Container: Leakage of unit dose cups that may occur at the seal.
MEDRAD Intego PET Infusion System - Pump  Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 radiation exposure during nuclear medicine diagnostic procedures.
Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Intego Pet Infusion System may produce particulates in radiopharmaceutical (RP) vials when the needle is inserted.
Dorothy Dawson Food Products dba Dawson Foods
Domestic: GA, UT, WI    Foreign:None  VA/DOD: None
Kustard Kwik Mix  80  50Lb Bags or 4000 Lb.
Dawson Food Products, Inc. initiated a voluntary recall of Creamy White Frosting Mix and Kustard Kwik Mix due to a supplier's recall of dried milk for potential contamination with Salmonella.
Kustard Kwik Mix, Item: L2902F0-DF, Lot: 103116B1  , UPC:58162 03052
Dawson Foods Inc. Creamy White Frosting Mix , 5 Lb Bags,  6  5Lb bags per case Creamy White, Ambient Storage
Creamy White Frosting Mix  138 6/5 cases or 4140 Lb
Dawson Foods Inc. Creamy White Frosting Mix, Dates of Manufacture: 05/11/2016 to 10/31/16, Item No:  F0800A0-DF, Lot Numbers:   051116B1, 072616B1, 092116B1, 060916B1, 092116B1, UPC: 58162 20003
Worldwide distribution - Nationwide U.S.A; International - Bermuda, Australia, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
VITROS Chemistry Products UPRO Slides, UPN 10758750000593,       Product Usage:  Quantitative measurement of total protein concentration in urine.
37,571 packs/90 slides totalling 3,381,390 slides
There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
Product Code REF 680 0120  Lot: GENs 14-18    Expiry Date range 01-JAN-2017 through 01-MAY-2018
Products were distributed in the following states:  AK, AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.    No foreign accounts
A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.
The junction box used in the bariatric bed may emit sparks and result in a fire.
Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida  33326, NDC 60505-3075-3.
Superpotent Drug: Product may not meet specifications throughout shelf life.
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial,  Rx only,  Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Devices were distributed in the following states: AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, & WI.    Devices were distributed in the following countries: Austria, Germany, Netherlands, Poland, Sweden, Switzerland and United Kingdom.
A complaint of the PRO2 jaw breaking prior to surgery being performed.
Model Numbers: PRO235, PRO240, PRO245, PRO250    Lot Numbers: 67102 to 68418
Shipped to VT, NJ, NY, FL, MI, WI, and VA
Cabana- Sour Cream & Onion Flavored Potato Chips  sold in 5 oz. bags
Bickel's Snack Foods, Inc. of York, PA is voluntarily recalling all snack products that were made with milk ingredients supplied by one of its' secondary seasoning component suppliers.
Troyer- Sour Cream & Onion Flavored Potato Chips  sold in 2oz., and 8.5 oz. bags.
2.0 oz 790 cases (18 bags/case), 8.5 oz 225 cases (9 bags/case)
Seyfert-Sour Cream & Onion Flavored Potato Chips  sold in 2 oz., 5 oz., 8.5 oz. bags
2.0 oz (888 cases/18 bags/case); 5.0 oz (8 cases/12 bags/case); 8.5 oz (2166 cases/9 bags/case)
Key Foods - Sour Cream & Onion Flavored Potato Chips  sold in 6 oz. bags
Dan Dee - Sour Cream & Onion Flavored Potato Chips  sold in 7/8 oz., 2 oz., and 8.5 oz. bags
7/8 oz. 499 cases (36 bags/case), 2 oz 2193 cases (18 bags case), 8.5 oz 1166 cases (9 bags/case)
Bickel's Sour Cream & Onion Flavored Potato Chips  sold in .75 oz., 2 oz., 7 oz., and 8.5 oz. bags.
.75 oz 179 cases (36 bags/case); 2 oz 57 (cases/18 bags/case), 7 oz 152 cases (12 bags/case), 8.5 oz 355 cases(9 bags/case)
Bon Ton-Sour Cream & Onion Flavored Potato Chips  sold in 2.75 oz, 1.5 oz. bags
2.75 oz (403 cases/12 bags per case) and 1.5 oz (49 cases/28 bags per case)
Blood products, collected from an ineligible donor, were distributed.
Blood and Blood Products for Reprocessing
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Soothing Goat Milk Bath Soak; The Goat Farm- Lavender,  16 oz. (453g)  glass jar
Firm received a complaint that a jar of bath soak burst, shattering the glass.
All batches. Complaint was from batch 164.
Worldwide Distribution - US including AL, AZ, ARK, CA, CO, CT, FL, GA. HI, KS, KY, IL, IN, IA, LA, MD, MA, MI, MN, MS, MO, MT, NE, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV and Internationally to Canada, Chile, & Japan
Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315  A tracheal tube is inserted into a patients mouth or nose for airway management
Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube.
Worldwide Distribution - USA (nationwide) Distribution including  Puerto Rico, and to the countries of :  Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Dominican Republic, Dubai, Finland, France, Germany, Ghana, India, Iran, Ireland,  Israel, Italy, Japan, Korea, Kuwait, Lebanon, Libya, Malaysia, Maldives, Mexico, Morocco, Netherlands, New Zealand, Norway,  Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates and United Kingdom.
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake.  The Revolution crashed into an elevator.
Serial Numbers: 101 to 2545 (Worldwide except China),  800101 to 800468 (China only)
Worldwide Distribution -  USA (nationwide) Distribution and to the countries of :  Australia, Canada, Chile, Spain, South Africa and Taiwan.
QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile)  SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile)    Accessories to TLS Surgical Drainage System
An incorrect sterility status on the label, non-sterile products labeled as sterile
9805  Orbital Volume Sizer Set with Tray (Non-sterile)  9951  Design M Malar Sizer Set (Silicone, Non-Sterile)  9952  Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile)  85000  Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile)    Accessories to Medpor Implants
9805  Orbital Volume Sizer Set with Tray (Non-sterile)  Lot M1311023  9951  Design M Malar Sizer Set (Silicone, Non-Sterile)  Lot M1305001  9952  Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile)  Lot M1603004  85000  Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile)  Lot M1603003
IN, VT, IL, GA, IA, NJ, CA, PA, Ontario, Quebec
Possible contamination of product with Salmonella as product includes the recalled milk and buttermilk powders .
Butterscotch Drops - MB 1000 [or 4000] Count; NET WT: 50 LBS
70 Milk Confectionery Coating - MB, NET WT: 2000 LBS
Possible contamination of product with Salmonella as product includes the recalled milk and buttermilk powders.
Cocie High Protein 90 White Confectionery Discs - MB, NET WT: 40 LBS
Worldwide distribution.  LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia.    LifePak 15 distributed nationwide in the US including Puerto Rico and to  ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIANA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LITHUANIA, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM.
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option.        Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions.
2584 units total (1501 units in the US; 1034 units international; and 49 units owned by Physio).  50 modules total
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option.     The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical).     The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
7 units in the US and 13 modules worldwide (5 international; and 8 owned by Physio)
DE  FL  GA  IA  ID  IL  IN  KS  MA  MD  ME  MI  MN  MO  MT  NJ  NY  OH  PA  VA  WI  WV
Cappuccino Snack Mix  Lot code: 20161027; Best By: 05/25/17    Net Wt: 10 lb (2-5lb bags)
As a result of an ingredient supplier recall, Dutch Valley is issuing a recall on Cappuccino Snack Mix due to the potential for it to be contaminated with Salmonella.
Franklin Farms East & Meadow Mountain Nutritional have initiated a recall because several products of theirs have the potential to be contaminated with Salmonella.
Market District Wasabi Soybeans; Net Wt. 6 OZ.;  Best By 3/6/17
Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Michigan, North Carolina, New Jersey, New Mexico, New York, Pennsylvania, Texas, Utah
in the ingredient list and the allergen statement, while the product actually contains PECAN as an ingredient.
Worldwide Distribution - US (Nationwide and, Puerto Rico) and Foreign distribution to the following countries: Australia, Brazil,  Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, and Venezuela.
VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integrated Systems. --- Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 --- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- Background: VITROS assays must be calibrated prior to use in order to be used to produce assay results. The Assay Data Disk (ADD) contains calibrator assigned values/ calculation data for multiple VITROS Calibrators and Lots. The Data Release Version (DRV) number identifies the version of the ADD.  Each time the ADD is updated with new ata, the DRV number increments higher. The DRV with the highest number contains the most   current data.  The VITROS 4600 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System are the only VITROS Systems that run the assays that are associated with VITROS Chemistry Products FS Calibrator   1.  VITROS FS Calibrator 1 is required to calibrate VITROS RF, dLDL, hsCRP, AMPH, BARB, BENZ, COCM,  CP, ASO, THC, d%A1c assays.  VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. VITROS FS Calibrator 1 is used on VITROS Systems to calibrate the following assays: VITROS AMPH, ASO, BARB, BENZ, COCM, d%A1c, dLDL, hsCRP, PCP, RF and THC Reagents
The company received a customer complaint for the inability to calibrate VITROS Chemistry Products dLDL Reagent when using VITROS FS Calibrator 1, Lot 91461 and ADD (DRV 5908).  Assay Data Disk (ADD) DRV versions 5904, 5905, 5906, 5907, 5908, 5909, and 5910 are all affected by this issue.
Lot 91461, Expiry Date 2018-09-19; Affected Assay Data Diskettes (ADD) Release Versions 5904 through 5910
Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated
Apheresis unit, incorrectly labeled as irradiated, was distributed.
Nationwide Distribution to CO, NY, and FL
Empowr PS Knee Tibial Insert; Model 343-14-709  The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
The Empowr PS Insert was reported as missing the impaction slot feature.
US Distribution was made to medical facilities in AL, IN, MI, PA and WI.
Merge RadSuite software.  The firm name on the label is Merge Healthcare, Hartland, WI.
8 sites have the potentially affected version
The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI.  There was no foreign/government/military distribution.
Merge PACS software.  The firm name on the label is Merge Healthcare, Hartland, WI.
29 sites have the potentially affected software
Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.
US: IL, WI, OH, NY, MT, FL, MD, IN, TN, TX, MN.    OUS: Italy, Taiwan Spain, Belgium, Canada, Netherlands, Sweden, Switzerland, Portugal, Brazil. Germany, Ireland,
InterFuse Tail Traction Tool, Part Number 9116.  The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse S or InterFuse T implant system.    The system has a modular design to allow the device to be assembled within the disc space to minimize the surgical window, while providing a footprint that approximates the excised nucleus.
Fit issues have been identified with the Tail Traction Tool (PN 9116) when used with the Interfuse T tailed implant.  The InterFuse T Tail may not fit into the Thru Hole in the instrument.
Fresh Foods Market Delicatessen Rotini Pasta Salad;  Net Wt. 10 oz . (283g)  Clamshell package.    UPC Code: WO2017019    Perishable; Keep Refrigerated;  Distributed by The Kroger Col., Cincinnati, OH
Retail store employee found that 10 oz. containers of Rotini Salad had the ingredient label for mustard potato salad; thus the allergen of wheat is not declared.
TN, MO,OH, KS, WI, MI, PA, IN, IL, NC, OK, TX, MN, IN,IL, MS, LA, NE, WI..
Best Choice French Vanilla Instant Pudding & Pie Filling, UPC 0 70038 31221 5, Distributed by Associated Wholesale Grocers, INC, 3.4 oz.
Subco Foods of Wisconsin was notified by their supplier that the high heat nonfat dry milk powder, an ingredient from that they supplied, was being recalled due to possible Salmonella contamination.
Bakers Corner Vanilla Instant Pudding & Pie Filling, UPC 0 41498 15253 6 Distributed by ALDI; Best Choice Vanilla pudding  UPC 0 70038 31218 5 Distributed by Associated Wholesale Grocers, INC(AWG)  and Always Save Vanilla Pudding, UPC 0 70038 31200 0, Distributed by Associated Wholesale Grocers, INC;   3.4 oz.
22,770 cases ALDI and 26,932 cases for all AWG.
Subco Foods of Wisconsin was notified by their supplier that the high heat nonfat dry milk powder, an ingredient that they supplied, was being recalled due to possible Salmonella contamination.
Best Choice Pistachio Instant Pudding & Pie Filling, UPC 0 70038 31220 8, 3.4 oz, Distributed by Associated Wholesale Grocers, INC.
Subco Foods of Wisconsin was notified by their supplier, that the high heat nonfat dry milk powder, an ingredient that they supplied, was being recalled due to possible Salmonella contamination.
Best Choice Lemon Instant Pudding & Pie Filling UPC 0 70038 31222 2, 3.4 oz, Distributed by Associated Wholesale Grocers, INC,  and Always Save Lemon Instant Pudding & Pie Filling; UPC 0 70038 31215 4, 3.4 oz,. Distributed by Associated Wholesale Grocers, INC .
Circle U Foods, Inc. Product Code: 1009008 NPP/Connie's Microwave Pizza Sauce Seasoning 25.00 Lbs.
Circle U Foods, Inc. Product Code: 908041 RCC/Cajun Buttermilk Dressing Bag Weight: 0.88 Lbs.
Circle U Foods, Inc. Product Code: 211013 NPP/Elmer's Deli Sauce Seasoning Pounds Per Bag/Box: 25.00 Lbs.
Circle U Foods, Inc. Product Code: 100002 AF/TV Taco Seasoning Bag Weight: 1.1250 Lbs.
Circle U Foods, Inc. Product Code: 900012 Razzoo's/Bayou Seasoning, RCC/Bayou Seasoning Bag Weight: 0.29 Lbs.
Worldwide Distribution -  USA ( nationwide) including PR and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY., and to the countries of :Canada, Austria, Belgium, Czech Republic, Denmark, Finland, France, French Polynesia, Guadeloupe, Monaco, New Caledonia, Reunion, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Australia, China, Egypt, Hong Kong, India, Iran, Japan, Jordan, Kuwait, Lebanon,  Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, Thailand, Tunisia, Turkey, United Arab Emirates, Argentina, Bermuda and Brazil.
Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command.  This behavior can only occur during an active, in-clinic interrogation/programming session with the Model 3200 S-ICD programmer.  There is no risk of this behavior occurring when the LATITUDE Patient Management System communicates with an S-ICD in an ambulatory setting.
TX, AR, CO, TN, FL, MO, NY, CA, GA, DE , IL, IN, MA, MI, TZ, AZ, BA, SC, MD
Herbal Choice Mari(TM) Organic Mouth Wash, 100 mL and 200 mL,  UPC 11120 200021
FDA sample was found to contain Pseudomonas aeruginosa.
MARICH Premium Chocolates;  Chocolate Caramel Heart; Our delicious caramel hearts in rich milk and dark chocolate;  Net Wt 4.25 oz. (120g)  UPC 797817-44440-9
Firm received report of customer finding the incorrect product in the Caramel Heart box. The product inside was Triple Chocolate Toffee which contains almonds that are not listed in the Caramel Hearts ingredient list.
Penrose-St Francis Health Services Blood Bank
Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis products, with unacceptably high platelet concentrations, were distributed.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood Bank Of San Bernardino And Riverside Counties
Apheresis Platelets, labeled with an incorrect volume, were distributed.
W125616627907 (double collection); W125616627644 (double collection); W125616627908 (double collection)
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis red cells, not meeting product specifications, were distributed.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.