Medline Industries, LP recalled 15 units of its perfusion syringe on October 27, 2025, due to potential biocompatibility failures. These failures may lead to risks of irritation and other serious health issues. Healthcare providers and patients must stop using the product immediately and follow the recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: E-Mail
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The recalled product is the Medline Perfusion Syringe, REF: DYNJ39223C, with UDI/DI 10193489621532 for each unit and 40193489621533 for the case. The affected lot number is 25FMJ081. This product was distributed nationwide in the United States, particularly in California.
Medline's recall follows BD's announcement regarding their Luer Tip Caps failing biocompatibility testing. While the tip cap does not contact patients directly, potential health risks include irritation and acute systemic toxicity.
There have been no reported injuries or incidents linked to this recall as of now. However, the potential for adverse reactions exists depending on contact duration.
Stop using the perfusion syringe immediately. Follow the recall instructions from Medline Industries, LP. Contact your healthcare provider or Medline for further guidance.
For more details, contact Medline Industries, LP via email. Visit the FDA recall page for additional information.
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