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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
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
High RiskFDA
Buddy Brew Coffee
Organic Cold brew BUDDY BREW COFFEE BOLT NITRO 10.5 oz. cans and 5 and 7.5 gallon kegs
Beverages·6,216 affected·Dec 19, 2019
High RiskFDA
Intuitive Surgical, Inc.
STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery usin...
Medical Devices·1,757 affected·Dec 19, 2019
High RiskFDA
Randox Laboratories, Limited
RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random a...
Medical Devices·4,040 affected·Dec 19, 2019
High RiskFDA
Philips Medical Systems Gmbh, Dmc
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Diagnostic Devices·116 affected·Dec 19, 2019
High RiskFDA
Northwest Gourmet Food Products Inc
Smoked Salmon Chowder, Pike Place Chowder brand, item #89201, distributed By PPC Trading Co. M. BOX #262 4580 Klahanie Drive SE Issaquah ...
Dairy·236 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Squaric Acid 0.1% Topical Solution (Clinic) 30 mL
Topical Drugs·1 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Progesterone 200 mg Troche
Drugs·1 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Tadalafil 6 mg Capsule
Oral Drugs·7 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Naltrexone 4.5 mg capsule
Oral Drugs·2 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars
Drugs·2 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars
Drugs·12 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Sildenafil 80 mg capsules
Oral Drugs·1 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Progesterone E4M SR 100 mg capsules
Oral Drugs·3 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Testosterone Topical Cream 4%
Topical Drugs·3 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Finasteride/Biotin 1 mg/50 mcg
Drugs·1 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Magic Bullet Supplement
Supplements·1 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Sildenafil 200 mg Troche (Clinic)
Drugs·1 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Progesterone 50 mg capsules
Oral Drugs·1 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Liothyronine (T3) 92.5 MCG
Drugs·4 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
DHEA/Pregnenol One 10.25 MG Cap
Drugs·1 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Tadalafil 20 mg Troche
Drugs·9 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
T3/T4 SR 9 mcg/38 mcg capsule
Oral Drugs·2 affected·Dec 18, 2019
High RiskFDA
Mprx, Inc. Dba Medical Park Pharmacy
Liothyronine (T3) 80 mcg SR cap
Drugs·5 affected·Dec 18, 2019
High RiskFDA
Covidien Llc
Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation...
Medical Devices·139,938 affected·Dec 18, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Diagnostic Devices·11,725 affected·Dec 18, 2019
High RiskFDA
Covidien Llc
Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approxima...
Medical Devices·139,938 affected·Dec 18, 2019
High RiskFDA
Covidien Llc
Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation o...
Medical Devices·139,938 affected·Dec 18, 2019
High RiskFDA
Covidien Llc
Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or...
Medical Devices·139,938 affected·Dec 18, 2019
High RiskFDA
Covidien Llc
Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation ...
Medical Devices·139,938 affected·Dec 18, 2019
High RiskFDA
Covidien Llc
Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation ...
Medical Devices·139,938 affected·Dec 18, 2019
High RiskFDA
Covidien Llc
Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
Medical Devices·139,938 affected·Dec 18, 2019
High RiskFDA
Covidien Llc
Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation o...
Medical Devices·139,938 affected·Dec 18, 2019