FDA (Devices) recall action 94136
The FDA (Devices) publishes a recall like this one as 29 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 29 pages.
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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.
Centurion Sterile Cotton Dental Rolls with weak seals may have compromised sterility. Affected products may allow contamination if the seal fails.
Medline Industries is recalling Centurion Clamp kits due to potential weak seals that could compromise sterility. Affected units were distributed nationwide and internationally.
Medline's Centurion Manual surgical kits may have weak seals that fail to maintain sterility. If seals breach, microorganisms could contaminate the sterile contents, posing infection risk during surgery.
MEDLINE INDUSTRIES is recalling Centurion 10mL sterile blood collection tubes due to weak seals that may compromise sterility and allow contamination if they fail.