Class II

Medical Device Recall: BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.

Maquet Medical Systems USA · January 16, 2024

Reason for Recall

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.

Distribution

Worldwide - US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

16520 worldwide; 6657 US

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1077-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Maquet Medical Systems USA Medical Device Recall: BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine. | SafeCheck