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High RiskFDA
Arrow International Inc
Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42563 JX1A
Surgical Devices·191 affected·Apr 23, 2019
High RiskFDA
Arrow International Inc
Arrowg+ard Blue Advance JACC Product Code: CDC 41552 JX1A
Medical Devices·77 affected·Apr 23, 2019
High RiskFDA
Arrow International Inc
Arrow PICC with Chlorag+ard Technology Product Code: CDA 45541 HPK1A
Medical Devices·20 affected·Apr 23, 2019
High RiskFDA
Arrow International Inc
Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45063 HPK1A
Medical Devices·350 affected·Apr 23, 2019
High RiskFDA
Arrow International Inc
Arrowg+ard Blue Advance JACC Product Code: CDC 42041 JX1A
Medical Devices·96 affected·Apr 23, 2019
High RiskFDA
Arrow International Inc
Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM
Medical Devices·2 affected·Apr 23, 2019
High RiskFDA
Arrow International Inc
Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A
Medical Devices·450 affected·Apr 23, 2019
High RiskFDA
Arrow International Inc
Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
Medical Devices·430 affected·Apr 23, 2019
High RiskFDA
Arrow International Inc
Arrow PICC Kit Product Code: ASK 45552 RWJ4
Medical Devices·1,840 affected·Apr 23, 2019
High RiskFDA
Arrow International Inc
Arrow PICC with Chlorag+ard Technology Product Code: CDA 44052 HPK1A
Medical Devices·180 affected·Apr 23, 2019
High RiskFDA
Arrow International Inc
Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 44063 VPS2
Medical Devices·48 affected·Apr 23, 2019
High RiskFDA
Arrow International Inc
Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45063 VPS2
Medical Devices·279 affected·Apr 23, 2019
High RiskFDA
Arrow International Inc
Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA
Medical Devices·66 affected·Apr 23, 2019
High RiskFDA
Gianni's Fine Food
Blue cheese & toasted walnut garlic balsamic vinaigrette, packaged in 6.3-fl. oz. glass bottle. The label is read in parts: "***Ingred...
Dairy·17 affected·Apr 22, 2019
High RiskFDA
Inopak Ltd
Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case,...
Drugs·17,850 affected·Apr 22, 2019
High RiskFDA
Inopak Ltd
Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in...
Drugs·17,850 affected·Apr 22, 2019
High RiskFDA
Inopak Ltd
Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large V...
Drugs·17,850 affected·Apr 22, 2019
High RiskFDA
Inopak Ltd
INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5...
Drugs·17,850 affected·Apr 22, 2019
High RiskFDA
Inopak Ltd
INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N...
Drugs·17,850 affected·Apr 22, 2019
High RiskFDA
Inopak Ltd
Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate)...
Drugs·17,850 affected·Apr 22, 2019
High RiskFDA
Inopak Ltd
Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, wi...
Topical Drugs·17,850 affected·Apr 22, 2019
High RiskFDA
Inopak Ltd
Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartri...
Drugs·17,850 affected·Apr 22, 2019
High RiskFDA
Inopak Ltd
ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12...
Drugs·17,850 affected·Apr 22, 2019
High RiskFDA
Inopak Ltd
AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles,...
Drugs·17,850 affected·Apr 22, 2019
High RiskFDA
Remedyrepack Inc.
Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, In...
Oral Drugs·44 affected·Apr 22, 2019
High RiskFDA
Cook Inc.
Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 0...
Medical Implants·12,968 affected·Apr 22, 2019
High RiskFDA
Cook Inc.
Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040...
Medical Implants·3,711 affected·Apr 22, 2019
High RiskFDA
Luminex Corporation
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Medical Devices·4 affected·Apr 22, 2019
High RiskFDA
Pacifico National, Inc. Dba Amex Pharmacy
BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biologic product was repackaged by AmEx Pharmacy 1515 Elizabeth ...
Injectable Drugs·249 affected·Apr 19, 2019
High RiskFDA
Philips North America, Llc
SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Medical Devices·518 affected·Apr 19, 2019
High RiskFDA
Isopure Corp
Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
Medical Devices·15 affected·Apr 19, 2019
High RiskFDA
Philips North America, Llc
SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Medical Devices·21,857 affected·Apr 19, 2019
High RiskFDA
Philips North America, Llc
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperat...
Medical Devices·12,719 affected·Apr 19, 2019
High RiskFDA
Isopure Corp
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
Medical Devices·1 affected·Apr 19, 2019
High RiskFDA
Isopure Corp
Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
Medical Devices·8 affected·Apr 19, 2019
High RiskFDA
Ethicon, Inc.
ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Sutur...
Medical Devices·1,296 affected·Apr 19, 2019
High RiskFDA
Auris Health Inc
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Medical Devices·158 affected·Apr 19, 2019
High RiskFDA
Philips North America, Llc
SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Medical Devices·12,543 affected·Apr 19, 2019
High RiskFDA
Torrent Pharma Inc.
Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactu...
Oral Drugs·65,184 affected·Apr 18, 2019
High RiskFDA
Torrent Pharma Inc.
Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactur...
Oral Drugs·28,464 affected·Apr 18, 2019
High RiskFDA
Torrent Pharma Inc.
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c...
Oral Drugs·331,764 affected·Apr 18, 2019
High RiskFDA
Torrent Pharma Inc.
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) ...
Oral Drugs·239,016 affected·Apr 18, 2019
High RiskFDA
Torrent Pharma Inc.
Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactur...
Oral Drugs·164,424 affected·Apr 18, 2019
High RiskFDA
Torrent Pharma Inc.
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10)...
Oral Drugs·54,084 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 22701 Material: 701050790
Medical Devices·0 affected·Apr 18, 2019