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

Recall Z-0633-2021 — HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.

U.S. FDA — Device Enforcement · United States · 2020-11-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0633-2021
Date of alert
2020-11-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Maquet Cardiovascular Us Sales, Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04037691773513
Reported risk: The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
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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