FDA (Devices) recall action 79192
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
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 615 units of Mallinckrodt Institute Percutaneous Gastrostomy Sets because wire guides may be loaded backwards into the holder.
Cook Inc. is recalling Wills-Oglesby Percutaneous Gastrostomy Sets because wire guides may be loaded backwards into the holder.
Cook Inc. is recalling Percutaneous Gastrojejunostomy Sets because wire guides may be loaded backwards into the holder.