Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1347-2023 — CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

U.S. FDA — Device Enforcement · United States · 2023-03-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1347-2023
Date of alert
2023-03-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Terumo Cardiovascular Systems Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00699753450868
Reported risk: Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.