FDA-Device2025-12-17Class IIPROCESSING DEFECT

Medline Perfusion Syringe recalled for defective BD Luer Tip Cap biocompatibility failure

Nationwide distribution

Check Medline Perfusion Syringe lot 25FMJ081

Medline is recalling specific batches of Medline Perfusion Syringes (model DYNJ39223C) that contain BD Luer Tip Caps. BD's testing found that certain tip cap trays failed biocompatibility tests, meaning the plastic may cause skin irritation, allergic reactions, or other adverse effects if it contacts patients during use. No injuries have been reported so far.

  • Check if you have Medline Perfusion Syringes with lot number 25FMJ081
  • Do not use affected syringes; set them aside
  • Contact your supplier or Medline for instructions on return or replacement
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.

Sold states
US Nationwide distribution in the state of CA.
Affected count
15 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

Official notice

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

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