FDA (Devices) recall action 71293
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.
Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
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.
Beaver-Visitec is recalling 384 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.
Beaver-Visitec International Inc. is recalling 268 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.
Beaver-Visitec International is recalling 585 ophthalmic procedure kits because the Devon Light Glove component may have holes or slits that compromise sterility.
Beaver-Visitec is recalling 214 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.
Beaver-Visitec International is recalling 621 ophthalmic procedure kits because the included Devon Light Glove may have holes or slits that compromise sterility.