FDA (Devices) recall action 76774
The FDA (Devices) publishes a recall like this one as 18 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 18 pages.
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
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 1,170 Dr. Wischmeier Packs because the sterile packaging of the included eye pads may be compromised.
Windstone Medical Packaging is recalling 1,330 Eye Packs because the sterile packaging of the included eye pads may be compromised.
Windstone Medical Packaging is recalling 100 Vitrectomy Packs because the sterile packaging of the included eye pads may be compromised.
Windstone Medical Packaging is recalling 376 plastic kits containing Medtronic Curity Eye Pads because the sterile packaging may be compromised.
Windstone Medical Packaging is recalling Vitrectomy Kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.
Windstone Medical Packaging is recalling 7,508 cataract packs because the sterile packaging of the included eye pads may be compromised.
Windstone Medical Packaging is recalling 172 Dicken Eye Packs because the sterile packaging of the eye pads may be compromised.
Windstone Medical Packaging is recalling 990 cataract kits because the sterile packaging of the included eye pads may be compromised.
Windstone Medical Packaging is recalling 20 PRK kits because the sterile packaging of the included eye pads may be compromised.
Windstone Medical Packaging is recalling 4,065 cataract kits because the sterile packaging of the included eye pads may be compromised.
Windstone Medical Packaging is recalling 169 ophthalmic packs containing Medtronic Curity Eye Pads because the sterile packaging may be compromised.
Windstone Medical Packaging is recalling 500 Setup Packs containing Medtronic Curity Eye Pads due to potential sterile packaging compromise.
Windstone Medical Packaging is recalling 260 Lasik Tray kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.
Windstone Medical Packaging is recalling 16 ENT kits because the sterile packaging of the included Medtronic eye pads may be compromised.
Windstone Medical Packaging is recalling Eye Cataract Packs because the sterile packaging of the included eye pad may be compromised.
Windstone Medical Packaging is recalling 700 Minor Operation Kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.
Windstone Medical Packaging is recalling 164 custom kits containing Medtronic Curity Eye Pads due to potential sterile packaging compromise.
Windstone Medical Packaging is recalling 12 Ortho Basic Packs because the sterile packaging of the included eye pads may be compromised.