Medline medical procedure kits recalled for catheter defects
What this means
Medline found that samples of several obstetric and gynecological procedure kits did not meet quality standards. The issues include surface irregularities on catheters, connectors that detached prematurely from catheter funnels, and catheters with diameters outside acceptable specifications.
- If your facility received these kits, stop using them and contact Medline with your kit numbers and lot numbers.
- Check the recalled kit numbers and lot numbers against your inventory.
- Return affected kits to Medline or your distributor for replacement or refund.
The agency's original wording
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-2501-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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