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High RiskFDA
Customed, Inc
Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures and patient care procedur...
Surgical Devices·40 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform surgical procedures and patient care procedures ...
Surgical Devices·800 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such...
Surgical Devices·8 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures suc...
Surgical Devices·85 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such...
Surgical Devices·238 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as...
Surgical Devices·550 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such...
Surgical Devices·132 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff to perform surgic...
Surgical Devices·1,148 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care proc...
Surgical Devices·144 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
Surgical Devices·60 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures su...
Cardiac Devices·47 affected·Jan 7, 2016
CriticalFDA
Heartware, Inc.
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OU...
Cardiac Devices·18 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as w...
Surgical Devices·55 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care...
Surgical Devices·24 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wou...
Surgical Devices·18 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff to perform surgical procedures and patient c...
Surgical Devices·4,400 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical procedures and patient care procedures s...
Surgical Devices·580 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures su...
Surgical Devices·168 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures su...
Surgical Devices·76 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures suc...
Surgical Devices·150 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such a...
Surgical Devices·80 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such a...
Surgical Devices·200 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures ...
Surgical Devices·380 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures and patient care procedures such as w...
Surgical Devices·4,550 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such...
Surgical Devices·540 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such ...
Surgical Devices·24 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900540 WOUND MANAGEMENT TRAY III Used by medical staff to perform surgical procedures and patient care procedures suc...
Surgical Devices·620 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures su...
Surgical Devices·800 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as woun...
Surgical Devices·32 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures ...
Surgical Devices·2,920 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900410 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedure...
Surgical Devices·96 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures suc...
Surgical Devices·540 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures suc...
Surgical Devices·72 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900740A ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures su...
Surgical Devices·108 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures suc...
Surgical Devices·25 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001202 LAMINECTOMY PK Used by medical staff to perform surgical procedures and patient care procedures such as wound...
Surgical Devices·42 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such a...
Surgical Devices·900 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures su...
Surgical Devices·60 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care p...
Surgical Devices·84 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such...
Surgical Devices·938 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to perform surgical procedures and patient care procedures such a...
Surgical Devices·45 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900996 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures suc...
Surgical Devices·111 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound...
Surgical Devices·280 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001061 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such a...
Surgical Devices·30 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001297 PREMIUM OBSTETRICAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care proce...
Surgical Devices·220 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care p...
Surgical Devices·30 affected·Jan 7, 2016
High RiskFDA
Wfr/aquaplast Corp
Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Ta...
Medical Devices·18 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9002256 NEUROSURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as w...
Surgical Devices·24 affected·Jan 7, 2016