Z-1077-2024 Class II Ongoing
FDA device recall Z-1077-2024 was initiated by Maquet Medical Systems USA on January 16, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 16520 worldwide; 6657 US.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2024
- Initiation Date
- January 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16520 worldwide; 6657 US
Product Description
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
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 Pattern
Worldwide - US Nationwide distribution.
Code Information
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