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

Recall Z-2149-2019 — Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794

U.S. FDA — Device Enforcement · United States · 2019-07-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2149-2019
Date of alert
2019-07-11
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)
70131093
Reported risk: The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended.
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.