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

Recall Z-2159-2018 — Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass

U.S. FDA — Device Enforcement · Germany · 2018-05-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2159-2018
Date of alert
2018-05-14
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Maquet Cardiopulmonary Ag
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04037691085555
Reported risk: This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
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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