Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
This recall has been terminated (originally issued July 11, 2019).
- Recall Initiated
- July 11, 2019
- Terminated
- December 11, 2020
- Recall Number
- Z-2149-2019
- Quantity
- 54
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
Lot 70131093; UDI 04037691741543
Root Cause
Under Investigation by firm
Action Taken
Urgent Medical Device Recall - Removal notification letters dated 7/11/19 were sent to customers.
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