FDA (Devices) recall action 77217
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
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.
Cook Inc. is recalling 29 Pereyra Ligature Carrier 75 devices because their reprocessing instructions do not provide sufficient detail for cleaning, disinfection, and sterilization.
Cook Inc. is recalling 46 Endoscopic Introducer/Extractor devices because their reprocessing instructions do not provide sufficient detail for cleaning, disinfection, and sterilization.
Cook Inc. is recalling 178 Clarke-Reich Laparoscopic Knot Pushers because the reprocessing instructions do not provide sufficient detail for cleaning, disinfection, and sterilization.
Cook Inc. is recalling 257 Pereyra-Raz Ligature Carriers because the provided reprocessing instructions do not contain sufficient detail for proper cleaning, disinfection, and sterilization.
Cook Inc. is recalling 698 Stamey Needles because the provided reprocessing instructions do not contain sufficient detail for proper cleaning, disinfection, and sterilization.