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High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices·230 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Foot Pack, Kit number AMS3637 convenience custom kits used for general surgery in hospital operating room
Medical Devices·85 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room
Medical Devices·130 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices·1,476 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Set Up Pack, Kit number PSS3574(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·16 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible fi...
Surgical Devices·1,400 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Major Kit, Kit number PHC1307(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·175 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible fir...
Surgical Devices·124 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible...
Cardiac Devices·36 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery in hospital operating room
Medical Devices·15 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in h...
Medical Devices·5,723 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenience custom kits used for general surgery in hospital operati...
Medical Devices·838 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room
Medical Devices·230 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit containing cover light handle soft, RX. The respo...
Surgical Devices·324 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on ...
Surgical Devices·72 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room
Medical Devices·1,780 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital...
Medical Devices·2,004 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible f...
Cardiac Devices·440 affected·Apr 22, 2015
High RiskFDA
Ge Healthcare
CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new sol...
Medical Devices·4 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Student Pack-NS, Kit number PSS2788 convenience custom kits used for general surgery in hospital operating room
Medical Devices·5 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospit...
Medical Devices·192 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Augmentation Mammoplasty Tray, Kit part number AMS2234. convenience custom kits used for general surgery in hospital operating room
Medical Devices·132 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible fir...
Surgical Devices·746 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·92 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room
Medical Devices·140 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on ...
Surgical Devices·200 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on t...
Surgical Devices·144 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating room
Medical Devices·20 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Robotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in hospital operating room
Medical Devices·33 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containing cover light handle soft, RX. The responsible...
Surgical Devices·64 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm ...
Surgical Devices·3,099 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, P...
Medical Devices·6,526 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible f...
Surgical Devices·658 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Face Pack, Kit number AMS3641 convenience custom kits used for general surgery in hospital operating room
Medical Devices·27 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in hospital operating room
Medical Devices·28 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·120 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Universal Pack, Kit number AMS2036 convenience custom kits used for general surgery in hospital operating room
Medical Devices·99 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits ...
Medical Devices·3,829 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for general surgery in hospital operating room
Medical Devices·85 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on th...
Surgical Devices·904 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Hall SAP, Kit number SRK1031(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·30 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Laparotomy Tray, Kit number PSS1538 convenience custom kits used for general surgery in hospital operating room
Medical Devices·32 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general surgery in hospital operating room
Medical Devices·48 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general surgery in hospital operating room
Medical Devices·5,388 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room
Medical Devices·288 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·1,599 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices·214 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices·1,144 affected·Apr 22, 2015