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High RiskFDA
Barilla America Ny, Inc.
Barilla MEDIUM SHELLS, 1 LB (454 g), GTIN 00076808002881, packed as twelve boxes in 1 case
Food·43 affected·Jul 2, 2015
High RiskFDA
Barilla America Ny, Inc.
Barilla Packaged Specifically for FoodService, PENNE RIGATE, 160 OZ (10 LBS) (4.54 kg), GTIN 1007680839242, packed as two bags per case.
Food·6,178 affected·Jul 2, 2015
High RiskFDA
Barilla America Ny, Inc.
Barilla PENNE, 8 X 1 LB (454 g) BOXES, [NET WT. 8 LB (3.63 kg)], GTIN 10076808034360, packed as a Multi-unit box, 8 units per case for s...
Food·9,360 affected·Jul 2, 2015
High RiskFDA
Barilla America Ny, Inc.
Barilla Pronto PENNE, 12 OZ (340 g), GTIN number 10076808005605, packed as 16 boxes per case, sold as individual units at retailer.
Food·82 affected·Jul 2, 2015
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
Injectable Drugs·314,600 affected·Jul 2, 2015
High RiskFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-00...
Injectable Drugs·189,912 affected·Jul 2, 2015
High RiskFDA
Mrp, Llc Dba Amusa
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
Medical Devices·551 affected·Jul 2, 2015
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Spirit One A-C Powered Hospital Bed
Medical Devices·143 affected·Jul 2, 2015
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Spirit One A-C Powered Hospital Bed
Medical Devices·143 affected·Jul 2, 2015
High RiskFDA
Silhouette Lift, Inc.
Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated pos...
Medical Devices·2,260 affected·Jul 2, 2015
High RiskFDA
Buckwheat Enterprises, Inc
All You Need Bread, Each loaf is package in a bag with a net wt. 1 lb. 14 oz., sold under brand Great Harvest Bread Co.
Bakery & Grains·174 affected·Jul 1, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomog...
Diagnostic Devices·44 affected·Jul 1, 2015
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery...
Medical Devices·74 affected·Jul 1, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomog...
Diagnostic Devices·13 affected·Jul 1, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomo...
Diagnostic Devices·2 affected·Jul 1, 2015
High RiskFDA
Myoscience Inc
iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually pac...
Surgical Devices·12 affected·Jul 1, 2015
High RiskFDA
Michael Foods, Inc.
Crystal Farms Simply Potatoes Shredded Hash Browns packaged as individual plastic bags Net Wt. 20 oz (1 lb 4 oz) 567 g; UPC 0 20169 22233...
Food·3,349 affected·Jun 30, 2015
High RiskFDA
Inn Foods Inc.
IQF Italian Cut Green Beans (each tote 1350 lbs) lot 880804 Harvest Delight Italian Green Beans, (Veg, mixed, FZN, Italian Blend, IQF...
Food·8 affected·Jun 30, 2015
High RiskFDA
Glorybee Inc
Turkish Organic Diced Apricots with Rice Flour (5-7 mm), FOODIMPEX brand, Item# 17496, product is packged in a white cardboard box. Net ...
Food·107 affected·Jun 30, 2015
High RiskFDA
Hospira Inc.
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- ...
Drugs·12,460,975 affected·Jun 30, 2015
High RiskFDA
Hospira Inc.
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- N...
Drugs·5,214,900 affected·Jun 30, 2015
High RiskFDA
Mylan Pharmaceuticals Inc
Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0...
Oral Drugs·1,068 affected·Jun 30, 2015
High RiskFDA
Remel Inc
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic stre...
Medical Devices·1,859 affected·Jun 30, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and...
Diagnostic Devices·1,032 affected·Jun 30, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures...
Diagnostic Devices·586 affected·Jun 30, 2015
High RiskFDA
Hitachi Medical Systems America Inc
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Medical Devices·33 affected·Jun 30, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemi...
Diagnostic Devices·6,801,375 affected·Jun 30, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and ...
Medical Devices·0 affected·Jun 30, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Ope...
Medical Devices·256 affected·Jun 30, 2015
High RiskFDA
Biotronik, Inc.
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK...
Cardiac Devices·768 affected·Jun 30, 2015
High RiskFDA
Remel Inc
PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal ...
Diagnostic Devices·4,420 affected·Jun 30, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
Medical Devices·60 affected·Jun 30, 2015
High RiskFDA
Becton Dickinson & Co.
Enterococcus Screen Agar QUAD Plate
Medical Devices·770 affected·Jun 29, 2015
High RiskFDA
Covidien Lp (formerly Nellcor Puritan Bennett Inc.)
OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
Respiratory Devices·105,831 affected·Jun 29, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedur...
Cardiac Devices·0 affected·Jun 29, 2015
High RiskFDA
Becton Dickinson & Co.
Vancomycin Screen Agar
Medical Devices·60,840 affected·Jun 29, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includi...
Cardiac Devices·0 affected·Jun 29, 2015
High RiskFDA
Covidien Lp (formerly Nellcor Puritan Bennett Inc.)
OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial ox...
Respiratory Devices·211,426 affected·Jun 29, 2015
High RiskFDA
Merit Medical Systems, Inc.
ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
Surgical Devices·950 affected·Jun 29, 2015
High RiskFDA
Atkins Indiana Distribution Center
Atkins Chocolate Candies  5 ct. cartons - UPC code 637480075558
Snacks & Candy·5,846 affected·Jun 27, 2015
High RiskFDA
Wismettac Asian Food
Seasoned Beanthread Salad (CHUKA ZENSAI), net wt. 2.2 lbs (1kg), Item No. 82021. Chinese style appetizer labeled as SEASONED BEANTHRE...
Produce·53 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 1...
Ophthalmic Drugs·40 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48
Injectable Drugs·55 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80
Injectable Drugs·98 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13389-1152-36
Drugs·55 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10
Drugs·55 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Drugs·750 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1398-47
Drugs·75 affected·Jun 26, 2015