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

Recall Z-1077-2024 — BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.

U.S. FDA — Device Enforcement · United States · 2024-01-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1077-2024
Date of alert
2024-01-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Maquet Medical Systems USA
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04058863080383
Reported risk: The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.