Medline open-heart and cardiac surgery kits recalled for catheter defects
Medline cardiac procedure kits recalled for catheter defects
Medline identified that certain batches of medical procedure kits used in open-heart and cardiac surgeries did not meet quality standards. Issues found include surface irregularities on catheters, connectors that may detach prematurely, and catheters with incorrect outer diameters. No injuries have been reported.
- Check if your facility has any of the affected kit lot numbers listed in the recall notice.
- Do not use affected kits for procedures.
- Contact Medline or your supplier for instructions on returning or replacing the kits.
- Review your surgical inventory immediately if you perform open-heart or cardiac procedures.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2487-2026More Medline recalls
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