Maquet Cardiopulmonary — Class II medical device recall Z-2149-2019
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2019-09-25, distributed in AR, CA, FL, GA, IA, IL, IN, KY…. The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous l
| Recall number | Z-2149-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2019-07-11 |
| Classified | 2019-09-13 |
| Reported by FDA | 2019-09-25 |
| Terminated | 2020-12-11 |
| Distributed | AR, CA, FL, GA, IA, IL, IN, KY, NC, NE, NM, NV, NY, OH, OR, TN, WI |
| Quantity | 54 |
| UPC / GTIN / UDI-DI | 04037691741543 |
| Lot numbers | 70131093 |
| Model numbers | 701052794, BEQ-HLS-7050USA |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2149-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.