Medline Industries, LP: Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿

Hazard

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

Details from the source

Reason for recall: 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 Distribution: Distribution US nationwide. Quantity: 650 Lot/code info: UDI-DI (case) 20197344019554¿ (ea) 10197344019557 Lots EP250324 EP250416 EP250512 EP250521 EP250609 EP250630 EP250710 EP250724

UPC codes

20197344019554, 10197344019557

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.