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

Recall Z-1862-2021 — The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14

U.S. FDA — Device Enforcement · United States · 2021-04-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1862-2021
Date of alert
2021-04-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Circulatory Technology Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00851997007004
Reported risk: The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
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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