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 92 Ortho Pack kits because they may contain defective gloves with splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 140 Mammoplasty Kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 20 Major Breast Packs containing Medtronic gloves that may have splits or holes, compromising sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they 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.
Medtronic is recalling disposable gloves used in custom surgical kits because they may contain splits or holes that compromise sterility.
Windstone Medical is recalling Percutaneous Entry 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 is recalling 30 Knee Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 290 units of Extremity Pack-N Brunswick kits 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.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in surgical kits.
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 224 Dr. Fritsch surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 249 Lumbar Laminectomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 816 Extremity Tray kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 2,225 surgical set-up packs because the disposable gloves included in the kits may contain splits or holes that compromise sterility.
Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES because they may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 545 podiatry kits because disposable gloves inside may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling Eye Tray kits (PSS1834 and PSS1939) because Medtronic gloves within the kits may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 58 Total Joint Packs because the disposable gloves inside may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling C-Section kits because the included Medtronic gloves 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 Packaging is recalling 54 Total Hip Packs because disposable gloves in the kits may contain splits or holes that compromise sterility.