FDA recall Z-0886-2026

Medline Industries, LP · Class II · device

Product

MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

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. 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.

Distribution

US Nationwide distribution in the state of CA.

Key facts

Status
Ongoing
Initiation date
2025-10-27
Report date
2025-12-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0886-2026