Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 4, 2026
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
What's affected?
- Product
- MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B
- Lot code
- 25LBI062
Additional details
UDI/DI 10195327548261 (each), 40195327548262 (case). Lot Numbers: 25LBI062, 25HBR967, 24JBK618, 24BBQ860.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 20 units.
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