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High RiskFDA
Assurance Infusion
BUP 40MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 15MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Drugs·45 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 3MG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Drugs·20 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion (713)-533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800
Drugs·7 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·2 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·2 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800
Drugs·166 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1
Medical Devices·155 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH
Surgical Devices·1,150 affected·Dec 20, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and bipla...
Diagnostic Devices·6 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
PICC Set- PR-35052-HPHNM
Medical Devices·0 affected·Dec 20, 2019
High RiskFDA
Physio-control, Inc.
LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
Cardiac Devices·29,952 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
Surgical Devices·250 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow Central Venous Catheterization Kit ASK-04200-UPM
Surgical Devices·140 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM
Surgical Devices·410 affected·Dec 20, 2019
High RiskFDA
Physio-control, Inc.
LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
Cardiac Devices·705 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC
Surgical Devices·0 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow EPIDURAL CATHETERIZATION KIT YC-02220
Surgical Devices·160 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000
Surgical Devices·540 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN
Surgical Devices·205 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow EPIDURAL CATHETERIZATION KIT CK-02220
Surgical Devices·1,360 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
(1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arr...
Medical Devices·2,126 affected·Dec 20, 2019
CriticalFDA
Almark Foods, Llc
Cage Free Hard-Cooked Eggs sold under the following brand names: Almark, Fresh Thyme, Giant Eagle, Kroger, Lucerne, Members Mark, Natural...
Food·628,531 affected·Dec 19, 2019
High RiskFDA
Buddy Brew Coffee
Organic Cold brew BUDDY BREW COFFEE BOLT Original 10.5 oz. cans and 5 and 7.5 gallon kegs
Beverages·2,344 affected·Dec 19, 2019
CriticalFDA
Almark Foods, Llc
Eggland's Best Hard Cooked Eggs
Food·628,531 affected·Dec 19, 2019
CriticalFDA
Almark Foods, Llc
PECKISH PERFECTLY BOILED FREE RANGE ORGANIC Egg Rancheros Flavor Distributed by PECKISH, LLC, Sonoma, CA 95476
Food·628,531 affected·Dec 19, 2019
CriticalFDA
Almark Foods, Llc
Bulk Pail Product - Almark Foods HARD COOKED EGGS Peeled Eggs INGREDIENTS: EGGS, WATER, CITRIC ACID sold under the following brand names:...
Beverages·6,854 affected·Dec 19, 2019
CriticalFDA
Almark Foods, Llc
Organic Hard Cooked Eggs sold under the brand names of Almark Foods, Inspired Organics, Kirkland Signature, O Organics, Pete & Gerry's Si...
Food·628,531 affected·Dec 19, 2019
CriticalFDA
Almark Foods, Llc
Almark Foods Classic ProBox Classic Flavor - Cage Free Eggs
Food·628,531 affected·Dec 19, 2019
CriticalFDA
Almark Foods, Llc
Almark Foods Smokehouse ProBox Cage Free Hard Cooked Eggs
Food·628,531 affected·Dec 19, 2019
CriticalFDA
Almark Foods, Llc
Free Range Hard-Cooked Hen Eggs sold under the brand names of Farmer's Hen House and Nellie's
Food·628,531 affected·Dec 19, 2019
CriticalFDA
Almark Foods, Llc
Eggland's Best Cage Free Hard Cooked Eggs
Food·628,531 affected·Dec 19, 2019
CriticalFDA
Almark Foods, Llc
Almark Foods Barbecue Probox Mini BBQ Flavor Nuts - White Medium Eggs
Food·628,531 affected·Dec 19, 2019
CriticalFDA
Almark Foods, Llc
Almark Foods Cage Free Hard Cooked Eggs w/Salt & Pepper
Food·628,531 affected·Dec 19, 2019
CriticalFDA
Almark Foods, Llc
Eggland's Best Cage Free Hard Cooked Eggs w/Salt & Pepper
Food·628,531 affected·Dec 19, 2019
CriticalFDA
Almark Foods, Llc
PECKISH PERFECTLY BOILED FREE RANGE ORGANIC Egg Distributed by PECKISH, LLC, Sonoma, CA 95476
Food·628,531 affected·Dec 19, 2019
CriticalFDA
Whole Foods Market
365 Everyday Value Dark Chocolate Caramel Sea Salt Sandwich Cremes Net Wt 7.75 oz (220g) UPC 9948247606 Paper carton boxes sold individually
Snacks & Candy·3,895 affected·Dec 19, 2019