FDAHealthDecember 22, 2025
Medline Industries, LP — Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿
⚠️ These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 22, 2025
Distribution US nationwide.
What's affected?
- Product
- Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿
- Lot code
- EP250324
Additional details
UDI-DI (case) 20197344019554¿ (ea) 10197344019557 Lots EP250324 EP250416 EP250512 EP250521 EP250609 EP250630 EP250710 EP250724
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 650.
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