Medline laparoscopy procedure kits recalled for catheter defects
Medline laparoscopy kits recalled for catheter defects
Medline identified defects in laparoscopy procedure kits (SKU DYNJ37378A) during an internal review. The catheter connector may detach prematurely, the catheter surface finish may be irregular, or the catheter diameter may not meet specifications.
- Check your inventory for kit SKU DYNJ37378A (lot number DYNJ37378A).
- Contact Medline for further instructions on affected units.
- Do not use kits with the identified lot number until you receive guidance.
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-2485-2026More Medline recalls
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