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

Recall Z-0934-2020 — Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.

U.S. FDA — Device Enforcement · United States · 2019-11-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0934-2020
Date of alert
2019-11-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Datascope Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
068400040310
Reported risk: Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
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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