FDA (Devices) recall action 93379
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.
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
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.
Medline is recalling 4,850 adult blood culture collection kits (lot numbers 23EMI373, 23EMF712, 23DMF155, 23CMH026) because components inside expired before the kit's labeled expiration date.
Medline's blood culture kit is being recalled because components inside the kit have expired before the kit's stated expiration date. This could affect the kit's ability to function properly.
Medline Industries is recalling 3,160 units of 24 Blood Culture Kits because components within the kit have expired before the overall kit's stated expiration date. Expired components may compromise device performance or test result accuracy.
Medline Industries is recalling 1,600 Central Line Blood Culture kits due to component expiration prior to the listed kit expiration date. Expired materials could compromise blood culture test accuracy.
Medline is recalling 1,770 Peripheral Blood Culture Draw kits because components within the kits have expired before the kit's stated expiration date.