WhichRecall
Class IIReported 2025-12-17

MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

Recalled by Medline Industries, LP

Reason for Recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps

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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.

Recall Number
Z-0886-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-10-27
Reported
2025-12-17
Distribution
US Nationwide distribution in the state of CA.
Code Info
UDI/DI 10193489621532 (each) 40193489621533 (case), Lot Number 25FMJ081
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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