Maquet Medical Systems USA: Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.

Hazard

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.

Details from the source

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. Quantity: 16520 worldwide; 6657 US Lot/code info: UDI-DI 04058863076355 Lots 3000301222, 3000319782, 3000327602 ***Added 3/21/24*** 3000333098, 3000352360, 3000357174

UPC codes

04058863076355

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.