Z-1764-2022Class II

BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal...

Name: Z-1764-2022 BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal...
Creator: Maquet Medical Systems USA
Published: 2022-07-22
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2022-07-22 / Open, Classified / root cause: packaging

FDA source

Maquet Medical Systems USA began a recall of BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of... on 2022-07-22. FDA classified it as Class II and gives the reason as "The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1764-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-22
Posted: 2022-09-19
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
Root cause tag: packaging
FDA root cause: Package design/selection
Action: On July 15, 2022, the firm notified affected customers via Urgent Medical Device Removal Expansion letter. The letter informed customers of the inclusion of additional product codes and lots into the earlier recall initiated on November 6, 2020. Customers were instructed to examine their inventory and identify any affected product on hand. Affected product in use may be continued to be used according to normal practices. Unused and unexpired affected product should be immediately returned to Getinge for credit. Please contact Getinge Customer Service at (888) 9GETUSA / (888) 943-8872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. At this time, the recalling firm has already implemented the more durable Tyvek accessory packaging in all product manufactured September 2021 and later.
Quantity in commerce: 206 US; 48,960 Worldwide
Distribution: Worldwide distribution - US Nationwide and the countries Canada and Australia.
Product codes and lots: UDI-DI: 04037691741543 Lots 3000183172, 3000183179, 3000183191, 3000183910, 3000184681

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1764-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1764-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-19
Z-1765-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-19
Z-1766-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-19
Z-1767-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-19

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)