FDA (Devices) recall action 88963
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.
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
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 Industries is recalling EVLP Convenience Pack/Kit due to a NaCl injectable component that expired in April 2020, despite the kit's label showing a later expiration date. Users may unknowingly use expired medication.
Medline is recalling Venous Access Pack-LF Convenience Kits because the included saline solution component expired before the kit's labeled expiration date, creating a quality and safety issue.
Medline Industries is recalling the Major Vascular CDS Convenience Kit because a 250 mL saline injectable component expired in April 2020, while the overall kit's expiration date was July 31, 2021. Medical professionals should stop using affected kits immediately.
Medline Industries is recalling the Neuro Convenience Kit because a NaCl injectable component expired in April 2020 while the kit's overall expiration date was later. The expired component may pose a safety risk.
Medline Industries is recalling the Bedside PICC CDS Convenience Kit because a saline injection bag component expired in April 2020 while the kit's expiration date was later. No injuries have been reported.