Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part number #317036 5 X 6.5 ST Bag Combo.  the firm decided to recall Precision Flow Rate Tubing and RMS HIgH-Flo Subcutaneous Safety Needles Sets due to the sterile barrier packaging being found to have gaps during post-sterilization inspection of one lot of flow tubing, in which 701 out of 3,195 units were rejected for not passing inspection.  The firm determined that the issue was large than just the one lot and recalled the product via March 10, 2016 Voluntary Medical Device Corrections and Removal Notification to customers.  The recall was conducted without FDA notification.
Mac Pin Non-Cannulated Screw, 6.5 x 60mm
Incorrect labeling for the lot of MAC Pins.  Although the pins are laser as  460  mm in length, the pins are 60 mm in length.
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005583
Lack of sterility assurance:  leaking containers which could lead to exposure to infectious agents.
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061 Model Number: 32-005582.
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005587
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005585
Apheresis Platelets, Leukocytes Reduced, Irradiated
Blood product, with a low platelet count, was distributed.
Product was shipped to the following states: IA, IL, MN, MO & WI.
Can Code - 0127A VZ Best By )CT 2019 & 0137A VZ Best By OCT 2019
Can Code: - 0137A LC Best By OCT 2019 & 0147A LC BEst By OCT 2019
Nationwide in the USA, Bermuda, and New Zealand
Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.
Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology,  791 Park of Commerce Blvd, Boca Raton, FL 33487.
7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.
Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.
Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Distributed domestically to AK, AL, AZ, CA, CT, FL, GA, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI
The 30 minute maximum tanning time has been reduced to 20 minutes.
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273    Product Usage:  The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a  crash cart  as well as for portable emergency response throughout a hospital.
Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death.
Worldwide Distribution - USA (nationwide) Distribution. There was also government and military distribution. Foreign distribution was made to Canada, United Arab Emirates, Bahrain, Canada, Switzerland, United Kingdom, Kuwait, Mexico, Malaysia, The Netherlands, New Zealand, Qatar, Saudi Arabia, Taiwan, and South Africa.
Alaris Syringe Pump, Model 8110.  The firm name on the label is CareFusion.    The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pumps on the market. The modules are indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous, subcutaneous or epidural. The Alaris Syringe pump and PCA modules can be connected to the Alaris PC unit which is the central programming, monitoring, and power supply component for the Alaris System. The syringe pump and PCA pump uses standard, plastic piston syringes and single-use administration sets with luer-lock connectors.
The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
UDI 10885403810015.  Product involved are those devices manufactured and/or serviced between 5/1/2013 through 4/30/2017.
Alaris PCA Pump, Model 8120.  The firm name on the label is CareFusion.    The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pumps on the market. The modules are indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous, subcutaneous or epidural. The Alaris Syringe pump and PCA modules can be connected to the Alaris PC unit which is the central programming, monitoring, and power supply component for the Alaris System. The syringe pump and PCA pump uses standard, plastic piston syringes and single-use administration sets with luer-lock connectors.
UDI 10885403812002.  Product involved are those devices manufactured and/or serviced between 5/1/2013 through 4/30/2017.
Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10
11,474 cartons of 10 syringes per carton
Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09.
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10
Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
New York Blood Center, Inc. dba HBVS Elmsford Donor Center
Blood products, collected from an ineligible donor, were distributed.
Blood and Blood Products for Reprocessing
Worldwide Distribution - US Nationwide in the states of MI, AL, AR, CA, CO, FL,  GA, IL, IA, LA, MS, NJ, NC, OH, OK, OR, PA, TN, TX, VA, WV, WI, MI, NY, MA, NV, RI, IN, WA, AZ, DC, Puerto Rico and the country of Canada.
Cordis S.M.A.R.T. Flex Biliary Stent System    Product Usage:  Is indicated for use in the palliation of malignant strictures in the biliary tree.
Germany; products were packaged at the Pfizer Manufacturing Deutshland Gmbh location and then distributed to other countries.  No product distributed in the United States or its territories.
FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMT G EP PR KR, FOR MANUFACTURING, PROCESSING OR REPACKAGING
Microbial Contamination of Non-Sterile Products
Publix brand Southern Style Diced Hash Brown Potatoes, net wt. 32 oz. package, is recalled because the firm received consumer complaints that foreign material was found in product.
B170322 is shown on package.  batch # 1002167476
Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50
Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only,  SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12
Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Distributed in the US to Kansas.    Distributed internationally to Australia, Finland, France, Germany, Hong Kong, Ireland, Japan, Netherlands, Norway, Sweden, Switzerland, Taiwan,  Turkey, United Kingdom.
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not  manufactured according to defined specifications.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Domestic: IL, GA    Foreign: Guadaloupe    VA/DOD: None
As I am Born Curly Argan Curl Defining Jelly, 8 oz., 12 bottles/case, packaged in an amber bottle with a teal pump
Product recalled due to the presence of Enterobacter gergoviae.
Domestic: AL, AR, CA, MA, KY, PA, GA, TX, IL, NC, WA, NJ, TN, OH, LA, SC, NY, IN, MI, MD, OK, FL, MO,     Foreign: UK, Canada, Germany, Jamaica,
KeraCare Hydrating Detangling Shampoo - Sulfate- free, 8oz., and gallons; 8 oz.-12 bottles/case; gallons- 4 per case; UPC: 9670838012, Item #53227; UPC: 9670833053, Item #53943
Lot 16G1503: 828 units, and Lot 16K3l03: 3984 units
Product recalled due to the presence of Enterobacter cloacae.
One medical device distributor in California.
DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE,   REF 801-05-042, NON STERILE, Qty 1  For use in orthopedic surgery.
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.
EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM,  REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.
EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1  For use in orthopedic surgery.
Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only.  Manufactured by: Hi-Tech Pharmacal Co., Inc.  Amityville, NY 11701.  NDC:  50383-311-47
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
United States: All states with the exception of: Alaska, Hawaii, Idaho, New Mexico, Rhode Island, South Dakota and Wyoming
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A    Product Usage:  The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA) or transaortic (TAo) approach to transcatheter aortic valve replacement.
A component in the Certitude Loader may have a  molding overflow defect that could detach during advancement of the delivery system and  potentially embolize from the loader into the patient.
The American National Red Cross - Southern Region
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA  19454, NDC 0093-5213-01.
Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arlington, TX 76006, NDC 58657-500-16
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Product was distributed to customers in Nebraska
Custom Corid 4.54 Add Pak, Medicated, For Beef and Dairy Calves, Amprolium 4.54 g/lb, Product Code No. 603906, Net weight 40 lbs Manufactured by Furst-McNess Company.
Medicated feed assayed low for amprolium
All product sold by Spice Chain was shipped within the United States.
Paprika Powder HyTop 12/2.5oz, Merchants
Spice Chain Corporation has decided to initiate a product recall of Paprika after receiving several  consumer complaints of finding beetles in retail containers.
Paprika Sweet American Garden 12/3.25oz, Global Food Export
Paprika HUN Kalosca 12/5o, World Finer Foods
Paprika Powder Shopper's Value 12/2.75oz, SuperValue
Paprika Hun Budapest 12/5oz, World Finer Foods
Paprika Powder Krasdale 12/2.75oz, Krasdale
Spice Chain Corporation has decided to initiate a product recall of Paprika after receiving several consumer complaints of finding beetles in retail containers.
Paprika PAPA 12/5oz, International Bazaar
Paprika Powder Guaranteed Value 12/2.75oz, C&S Distribution
This product was distributed  within the United States and affected manufacturing in Maryland, Pennsylvania, New Jersey, North Carolina and Virginia.
Sugar Syrup / Bulk / Tanker Truck #1 & 2
diameter / steel wool.  The firm, upon confirming that the material did come from their Tank Truck #1 filled with Sugar Syrup initiated a recall.  The firm has not received any notification of injury or sickness or deaths from consumption by any customers finished goods made with our products.
Worldwide Distribution - USA (nationwide) including Puerto Rico and Hawaii and to the countries of : Australia, Austria, Belgium, Canada, Dominican Republic, Estonia , Finland, France, Germany, Hanover, Hong Kong, Israel, Italy, Japan, Jonesboro, Korea, Malaysia. Netherland, New Zealand, Norway, Poland, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, UAE, and United Kingdom.
Mobile Mini C-arm system Part # 1000-0004.     Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user
Mobile Mini C-arm system Part # 1000-0004-FD.    Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
Mobile Mini C-arm system Part # 1000-0001.     Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
Mobile Mini C-arm system Part # 1000-0005.     Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
55ct, individual apples on trays in cardboard tray  boxes
Nyblad Orchards Inc. initiated a voluntary recall of multiple varieties of whole fresh apples due to potential contamination with Listeria monocytogenes.
NOI LOT #163, #164, #165, #166, #167, #168, #169, #159, #160, #173, #174.  These are on all plastic bag enclosures, mesh labels, and case labels for every pack.  UPC #4129, #4131 Fuji Apples For Loose Apples
NOI LOT #163, #164, #165, #166, #167, #168, #169, #159, #160, #173, #174.  These are on all plastic bag enclosures, mesh labels, and case labels for every pack.
NOI LOT #163, #164, #165, #166, #167, #168, #169, #159, #160, #173, #174.  These are on all plastic bag enclosures, mesh labels, and case labels for every pack.    UPC#3283 Honey crisp Apples For Loose Apples
Apple Ridge 5lb, 2-3/4  apples, packaged in red net mesh bags
NOI LOT #163, #164, #165, #166, #167, #168, #169, #159, #160, #173, #174.  These are on all plastic bag enclosures, mesh labels, and case labels for every pack.  UPC #4129, #4131 Fuji Apples For Loose Apples  UPC#3283 Honeycrisp Apples For Loose Apples
Domestic: Michigan, Georgia, Missouri, Indiana and Ohio    Foreign/VA/DOD: None
Gala, whole fresh apples;  Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Trays-113ct (5trays per case), 55, 60, 78ct (2trays per RPC case) 2# & 3# - 12 bags per case, 5# - 8 bags per case
Jack Brown Produce, Inc. initiated a voluntary recall of multiple varieties of apples following notification from the supplier that product may be contaminated with Listeria monocytogenes.
Golden Delicious whole fresh apples;  Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Trays-113ct (5trays per case), 55, 60, 78ct (2trays per RPC case) 2# & 3# - 12 bags per case, 5# - 8 bags per case
Golden Del., Gala, Fuji, Honey Crisp;  Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Trays-113ct (5trays per case), 55, 60, 78ct (2trays per RPC case) 2# & 3# - 12 bags per case, 5# - 8 bags per case
Fuji, whole fresh apples;  Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Trays-113ct (5trays per case), 55, 60, 78ct (2trays per RPC case) 2# & 3# - 12 bags per case, 5# - 8 bags per case
Haldiram's Fresh Paneer Traditional Indian Soft Cottage Cheese, Net Weight 800g (28.2 oz)
Florida Department of Agriculture and Consumer Services (FDACS) collected a sample of Fresh Paneer Traditional Indian Soft Cottage Cheese 100% Vegetarian from a local grocery store that tested positive for Listeria monocytogenes.  The sample was imported by Kotecha Brothers LLC.
Batch No. 26 GQ (KB)  Best Before  07/28/2018
CA, FL, IA, IN, KS, MA, MD, MO, NY, OH, PA, TX, VA, WI
Light String Cheese, Part Skim Mozzarella cheese, sold under the following brands and package sizes:    1.  Fit & Active, 10 oz,.,  12 individually wrapped pieces.  UPC 041498-190293;     2.  LIDL, 10 oz., 12 individually wrapped pieces.  BEST BY 29MAR18L3    3.  Market Pantry, 5 oz,.,  6 individually wrapped pieces.  UPC 085239-116951  4.   Market Pantry, 10 oz., 12 individually wrapped pieces.  UPC 085239-118122;    5.  AHOLD,  8 oz., 8 individually wrapped pieces.  UPC 688267-152757;    6.  AHOLD 16 oz., 16 individually wrapped pieces.  UPC 688267-129667;    7.  AHOLD,  24 oz., 24 individually wrapped pieces.  UPC 688267-044823.
1.  Fit & Active  BEST BY 26MAR18G1, BEST BY 05APR18G1,  BEST BY 05APR18G2, BEST BY 05APR18G3.   2.  LIDL  BEST BY 29MAR18L3  3.  Market Pantry 5 oz..  USE BY 05APR2018 L3  4. Market Pantry 10 oz., USE BY 05APR2018 L3    5.  AHOLD  8 oz.  USE BY 04052018 L3  6.  AHOLD 16 oz. USE BY 04052018 L3  7.  AHOLD 24 oz.USE BY 04052018 L3
Frozen Southern Style Biscuits;  25 oz. bags (12 count)
200 cases distributed; 12 - 25 oz. bags per case; 12 count biscuits per bag
Tennessee Dept. of Agriculture tested the product which was found positive for Listeria monocytogenes.
All Best Buy Dates being recalled for UPC 86854-02591 to include violative lot with Best By 5/5/18.
Frozen Buttermilk Biscuits 25 oz. bag (12 count) and 44 oz. bag (20 count)
161 cases distributed (25 oz bags), 168 Cases distributed (44 oz. bags)
UPC 8685404014 (25 oz.)and UPC 8685404894 (44 oz.; 20 ct.); All Best By Dates under these SKUs are being recalled.
Smoked salmon in 1.5 oz. and 8 oz. packages
Product may be contaminated with Listeria monocytogenes.
Nationwide. The affected lot was shipped to addresses in 22 States:    Alaska, Arizona, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Minnesota, Montana, North Carolina, New Jersey, Ohio, Pennsylvania, West Virginia, Wisconsin.
SHS Wel-Plan Wheat and Corn Strach Baking Mix , 400 g box,Cardboard carton,  18 cartons per case, but distributed by individual unit (carton).
Nutricia North America, Inc. has decided to recall SHS Wel-Plan Baking Mix , 400 g box because testing of the product has detected a low level (0.74 cfu/g) contamination of Klebsiella pneumonia.     The product is a baking mix and is intended to be cooked, which would kill K. pneumonia.  The recall is being conducted out of an abundance of caution to avoid the risk that some consumers may misuse the product and consume it without cooking.
Item code 105175, Lot code 2417 and UPC code 74973501-8644
CO YO Coconut Yogurt Alternative CHOCOLATE, 5.3 oz and 12 oz. plastic container, 6 packages per case.  Store between 36 and 42 F.  Manufactured by COCONUTHEAD, LLC, Albuquerque NM; Distributed by UNFI and KeHE
Coconuthead LLC is recalling CO YO Coconut Yogurt Alternative CHOCOLATE due to container bloating.
BB 01/02/18   found printed on side of container lid
The product was distributed to the following states New York, New Jersey, Florida, Illinois and North Carolina .
Daisy s Bakery Inc., Gourmet Concha, 4 oz. / 1 per package, Plastic Bag, 12 units per case
Daisy s Bakery Inc. has decided to recall Gourmet Concha, 4 oz., because the product is mis-labeled and has an undeclared milk allergen.
AL, DC, GA,  KY, MD, MS, NC, NJ, NY, OH, PA, SC, TN, VA,
365 brand Egg Nog, Grade A; 1 qt. and 1/2 GAL; and    Harrisburg Dairies brand Egg Nog, Grade A; 1/2 GAL, 1 Quart, 16 FL. OZ.
Dried Egg Yolks was not specifically stated in ingredient statement
Distributed nationwide in the USA, Uzbekistan, and Myanmar
Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046 INDIA, NDC 43598-611-11
Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.
924 small packages and 911 Large packages
New Seasons Market Grab and Go Pre-Packaged Macaroni and Cheese is recalled due to undeclared egg.
Packed on dates: Dec 19, 17 to Dec 28, 17.    All sell by dates including and up to Jan 02, 18.  (means January 2, 2018).
U.S. distribution to the following: CA, IN, VA, PA, FL, CO, GA, KY, AL, TN.    No foreign distribution.
Wahon Slice Shitake Mushroom  2.5 oz. (71g)  UPC : #737483336851
U.S. distribution to the following: CA., FL, PA, MA, OR, OH, MO, NY, TX, VT, NJ.    No foreign distribution.
The Coconut Cult  Coconut Cream  Probiotic Coconut Yogurt  NET WT. 8 OZ, 16 OZ, 32 OZ  UPC 611138765282, 611138765275, 611138765268
Products listed sodium caseinate in allergen statement; however it did not further identify the allergen of milk.
The Coconut Cult  Mango Cream  Probiotic Coconut Yogurt  NET WT. 8 OZ, 16 OZ, 32 OZ  UPC 611138765244, 611138765251, 611138765237
107 domestic accounts  15 US Govt accounts  682 Foreign Accounts  3 Mexico accounts  12 Canada accounts
Philips Healthcare Brilliance iCT computed tomography x-ray system
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs,  the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
Brilliance iCT - 728306  Devices manufactured 03/05/2009 to present.
Philips Healthcare IQon Spectral CT computed tomography x-ray system
IQon Spectral CT 728332    Devices manufactured 03/05/2009 to present.
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Brilliance iCT SP - 728311    Devices manufactured 03/05/2009 to present.
Philips Electronics North  America Corporation
Worldwide Distribution - US Distribution and to the countries of : France, Germany, Luxembourg and New Zealand.
CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system    CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography
The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and  spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified distance.
Human corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.