FDA (Devices) recall action 71968
The FDA (Devices) publishes a recall like this one as 150 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 150 pages.
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom kit were recalled because gloves may contain splits or holes compromising sterility.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Windstone Medical Packaging is recalling 18 OB/GYN kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 648 Dr Mullins surgical kits because the Medtronic gloves inside may have splits or holes that compromise sterility.
Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES because splits or holes may compromise sterility in custom surgical kits.
Windstone Medical Packaging is recalling 1,164 custom surgical kits because the disposable gloves included may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 204 plastic packs used in general surgery because the included Medtronic gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 132 Augmentation Mammoplasty Kits because the disposable gloves included may contain splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Windstone Medical Packaging is recalling 2,048 Dr. Landi EVLT Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 40 Lipo Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Windstone Medical Packaging is recalling 16 surgical Set Up Packs because they may contain defective gloves that compromise sterility.
Windstone Medical Packaging is recalling 1,780 Transvaginal Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling Head and Neck surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling Student Pack-NS surgical kits because the Medtronic gloves included may have splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Windstone Medical is recalling 3,829 Extremity Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 246 Cath Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 505 breast pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 184 laparoscopy kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling Minor Ortho Packs because disposable gloves in the kits may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 3,104 shoulder packs used in general surgery because the disposable gloves included in the kits may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 56 D&C/GYN/Hysteroscopy Packs because the included Medtronic gloves may have splits or holes that compromise sterility.
Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES found in Windstone custom surgical kits because the gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 168 General Surgery Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.