Medline medical procedure kits recalled for catheter defects
Medline procedure kits recalled for catheter defects
Medline identified that certain batches of carotid neuro and VP shunt procedure kits did not meet performance specifications. Issues include surface irregularities on catheters, connectors that may detach prematurely, and catheters with incorrect outer diameter measurements.
- Check if your facility has received affected kits with the listed lot numbers.
- Do not use affected kits for procedures.
- Contact Medline for instructions on returning or replacing the kits.
- Consult the full recall notice for complete lot numbers and UDI codes.
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-2500-2026More Medline recalls
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