FDA (Devices) recall action 75746
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.
Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.
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.
Busse Hospital Disposables is recalling surgical instrument trays that contained recalled Covidien Devon Light Gloves.
Busse Hospital Disposables is recalling Carpal Tunnel Packs because they contained Devon Light Gloves subject to a labeling update.
Busse Hospital Disposables is recalling Breast Pack Surgical Instrument Trays because they contained gloves subject to a labeling update.