Z-0633-2021Class II

HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 -

Name: Z-0633-2021 HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 -
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2020-11-20
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2020-11-20 / Terminated / root cause: packaging

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the... on 2020-11-20. FDA classified it as Class II and gives the reason as "The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0633-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-20
Posted: 2020-12-17
Terminated: 2024-11-07
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Actions to be taken: Please examine your inventory immediately to determine if you have any of the affected HLS Set Advanced with the product codes and lot numbers listed on page 1 of this notice and acknowledge that you have received this notification by following the instructions below. If an affected device is already in use, please continue using according to normal practices. Should you have any un-used and un-expired affected product you are eligible to return the affected product for credit. Please contact Getinge Customer Service at (888) 9GETUSA / (800) 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. Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided, arrange for pickup with the designated delivery service provider. Please also enter the affected lot numbers, quantity and RMA number provided by Customer Service in the spaces provided on the Medical Device Recall Expansion - Removal Response Form on Page 4 of this letter, if you are returning products to Maquet/Getinge. Please complete and sign the attached MEDICAL DEVICE RECALL Removal RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to (800) 866-5751. This voluntary recall only affects the products listed on page 1; no other products are affected by this voluntary recall. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax using the following: " Online: www.accessdata.fda.gov/scripts/medwatch/ " Regular Mail: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Mexico, Moldavia, Montenegro, Morocco, Myanmar, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand,Turkey, United Arab Emirates, United Kingdom, Vietnam.
Product codes and lots: Model Number: BEQ-HLS 7050 Part Number: 70105.2794 UDI Code: 04037691773513 Lot Codes: 70130364, 70132269, 70133476, 70133592, 70133623, 70133624, 70133625, 70134790, 70135038

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0633-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0632-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0633-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17

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)