Maquet Medical Systems USA Recall 93849
Description: 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 Recall 93849 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1077-2024 |
| Event ID | 93849 |
| Event Description | BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine. |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution. |
| Quantity | 16520 worldwide; 6657 US |
| Recall Reason | 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. |
| Device Classification | 20240221 |
| Device 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 |
| Center Classification Date | 20240213 |
| Recall Initiation Date | 20240116 |
| Recalling Firm | Maquet Medical Systems USA |
| Initial Notification | Letter |
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