FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular Us Sales, Llc: Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
- Recall number
- Z-2149-2019
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Product
- Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
- Status
- Terminated
- Initiated
- 2019-07-11
- Posted
- not on file
- Terminated
- 2020-12-11
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- Urgent Medical Device Recall - Removal notification letters dated 7/11/19 were sent to customers.
- Quantity
- 54
- 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, serial or model codes
- Lot 70131093; UDI 04037691741543
- 510(k) numbers
- ["K112360"]
- PMA numbers
- not on file
- Product code
- DTZ
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28