Z-2149-2019 Class II Terminated
FDA device recall Z-2149-2019 was initiated by Maquet Cardiovascular Us Sales, Llc on July 11, 2019 and is designated Class II. Reason for recall: The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) con… The recall status is terminated (terminated December 11, 2020). Affected quantity: 54.
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2019
- Initiation Date
- July 11, 2019
- Termination Date
- December 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54
Product Description
Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
Reason for Recall
The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended.
Distribution Pattern
The products were distributed to the following US states: AR, CA, FL, GA, IA, IL, IN, KY, NC, NE, NM, NV, NY, OH, OR, TN, and WI.
Code Information
Lot 70131093; UDI 04037691741543