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

Recall Z-2029-2014 — Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.

U.S. FDA — Device Enforcement · United States · 2014-04-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2029-2014
Date of alert
2014-04-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Terumo Cardiovascular Systems Corporation
Product category
device
Product type
Devices
Reported risk: During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
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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