Medline urethroplasty procedure kits recalled for catheter defects
Medline urethroplasty kits recalled for catheter defects
Medline identified quality issues in certain urethroplasty procedure kits during an internal review. The catheters had surface irregularities, connectors that could detach prematurely, and some did not meet size specifications.
- Check if your facility has kits with lot numbers 23DLA834, 23BMC463, 23AMA685, 23AMB905, 22LMG466, 22LMB983, 25JBD225, or 25HBW236.
- Do not use affected kits for urethroplasty procedures.
- Contact your Medline representative or the FDA with questions about your specific lot numbers.
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-2495-2026More Medline Industries, LP recalls
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