FDA (Devices) recall action 73465
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.
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.
Avid Medical is recalling 240 MOHS procedure trays because they contained a latex dressing that was not labeled as such.
Avid Medical is recalling 20 Pediatric Kidney Biopsy Trays because they contain a latex dressing that was not labeled as such.
Avid Medical is recalling 240 MOHS procedure kits that included a latex-containing dressing without proper labeling.
Avid Medical is recalling 200 custom procedure trays that included latex-containing Telfa dressings without latex warnings. The products were distributed to Virginia and Massachusetts.