FDA-Device2019-09-25Class II
Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
Maquet Cardiovascular Us Sales, Llc
Hazard
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.
Sold states
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.
Affected count
54
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2149-2019Don't want to check this manually?
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