United StatesMEDLINE PERFUSION SYRINGE (REF DYNJ39223C), Lot 25FMJ081, UDI/DI 10193489621532 (each) 40193489621533 (case), distributed nationwide in the US with units in CA (15 units), is subject to a recall. It was recalled because BD Luer Tip Caps included in certain Medline kits failed routine biocompatibility testing, and although the cap covers a small, non‑patient‑contact area of the syringe, the failure could potentially lead to sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis.
What's being recalled
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
Recalling firm: Medline Industries, LP, Northfield, IL, United States.
How to identify it
UDI/DI 10193489621532 (each) 40193489621533 (case), Lot Number 25FMJ081
The hazard
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the state of CA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)