Maquet Medical Systems USA: BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. 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 04058863080383 Lots 3000280906, 3000280907, 3000280908, 3000280909, 3000282253, 3000282254, 3000282255, 3000291127, 3000300688, 3000314506, 3000316206, 3000316600, 3000317531, 3000317532, 3000318850, 3000318851, 3000318852, 3000318853, 3000319748, 3000319749, 3000319750, 3000319751, 3000319778, 3000319781, 3000323082, 3000323084, 3000323085, 3000324495, 3000324496, 3000324497, 3000324499, 3000325557, 3000325558, 3000325559, 3000327120, 3000327121, 3000328404, 3000328405, 3000334413, 3000334414, 3000336487 ***Added 3/21/24*** 3000330091, 3000330092, 3000330094, 3000330095, 3000330096, 3000333095, 3000333096, 3000333097, 3000334409, 3000334410, 3000336488, 3000337834, 3000342904, 3000342905, 3000342906, 3000342907, 3000342908, 3000344446, 3000344447, 3000344471, 3000344472, 3000344474, 3000346048, 3000346049, 3000346050, 3000346051, 3000346052, 3000348543, 3000348546, 3000348552, 3000348553, 3000349793, 3000349795, 3000349796, 3000349797, 3000352614, 3000352615, 3000352616, 3000352617, 3000353439, 3000353440

UPC codes

04058863080383

Source

Official record: FDA (Device enforcement) ↗

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