Medline Pelvic Lap Pack recalled for catheter defects and connector issues
What this means
Medline identified quality issues in representative samples of its Pelvic Lap Pack medical procedure kit (SKU DYNJ53820B). Problems include surface irregularities on the catheter, premature detachment of the catheter connector, and instances where the catheter diameter fell outside specification. A total of 20 units were affected.
- Check your medical supply inventory for kit number DYNJ53820B and lot numbers 25LBI062, 25HBR967, 24JBK618, or 24BBQ860.
- Contact Medline Industries for instructions on returning or replacing affected units.
- Do not use kits from the recalled lot numbers until you receive further guidance.
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-2502-2026More Medline recalls
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- 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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