Z-2149-2019Class II

Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number...

Name: Z-2149-2019 Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2019-07-11
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2019-07-11 / Terminated

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794 on 2019-07-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2149-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-11
Posted: 2019-09-13
Terminated: 2020-12-11
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
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
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.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall - Removal notification letters dated 7/11/19 were sent to customers.
Quantity in commerce: 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.
Product codes and lots: Lot 70131093; UDI 04037691741543

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2149-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2149-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-25	2019-09-13

Product code DTZ

K112360Class IIQuadrox-I Microporporous Membrane Oxgenator Series and Qudrox-Id Diffusion Membrane Oxygenators SeriesMaquet Cardiopulmonary, AG / cleared 2011-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)