FDA (Devices) recall action 83239
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Incomplete packaging seal of sterile 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.
Andover Healthcare Inc. is recalling 8,500 cases of sterile Co-Flex NL 4-inch wound dressings because of incomplete packaging seals that may compromise sterility.
Andover Healthcare Inc. is recalling 1,798 cases of sterile Co-Flex NL 3-inch wound dressings because of incomplete packaging seals that may compromise sterility.
Andover Healthcare Inc. is recalling 1,050 cases of Sterile Co-Flex Med 4-inch wound dressings because of incomplete packaging seals that may compromise sterility.
Andover Healthcare Inc. is recalling 269 cases of Sterile Co-Flex Med 3" wound dressings due to incomplete packaging seals that may compromise sterility.
Andover Healthcare Inc. is recalling 330 cases of Sterile Co-Flex LF2 3" wound dressings because of incomplete packaging seals that may compromise sterility.
Andover Healthcare Inc. is recalling 1,759 cases of sterile Co-Flex LF2 wound dressings because of incomplete packaging seals, which may compromise sterility.