Z-1077-2024Class II

BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP...

Name: Z-1077-2024 BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP...
Creator: Maquet Medical Systems USA
Published: 2024-01-16
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2024-01-16 / Open, Classified / root cause: manufacturing process

FDA source

Maquet Medical Systems USA began a recall of BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine on 2024-01-16. FDA classified it as Class II and gives the reason as "The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1077-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-16
Posted: 2024-02-13
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On January 16, 2024, the recalling firm began notifying affected customers via URGENT MEDICAL DEVICE CORRECTION letters. Customers were instructed to dispose of any Emergency Priming Line from a previously opened, affected HLS set. Customers should only use the Emergency Priming Line from a newly opened HLS Set. Device users should always have an HLS Set ready as a backup during therapy. The remaining components of the backup HLS Set must be disposed of after extraction of the Emergency Priming Line. Please reach out to Getinge Customer Support for the issuance of a replacement HLS Set at no cost. Customers may also return unopened/unexpired affected HLS Sets by contacting Customer Support. If an affected Emergency Priming Line is already in use, the firm advises it should remain in use due to increased potential risk of stopping this emergency procedure. Users should monitor the patient closely for signs of infection. Contact Getinge Customer Support: (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). ***Updated 3/21/24*** Additional lots identified. Firm notified affected customers on March 21, 2024.
Quantity in commerce: 16520 worldwide; 6657 US
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: UDI-DI 04058863080383 Lots 3000280906, 3000280907, 3000280908, 3000280909, 3000282253, 3000282254, 3000282255, 3000291127, 3000300688, 3000314506, 3000316206, 3000316600, 3000317531, 3000317532, 3000318850, 3000318851, 3000318852, 3000318853, 3000319748, 3000319749, 3000319750, 3000319751, 3000319778, 3000319781, 3000323082, 3000323084, 3000323085, 3000324495, 3000324496, 3000324497, 3000324499, 3000325557, 3000325558, 3000325559, 3000327120, 3000327121, 3000328404, 3000328405, 3000334413, 3000334414, 3000336487 ***Added 3/21/24*** 3000330091, 3000330092, 3000330094, 3000330095, 3000330096, 3000333095, 3000333096, 3000333097, 3000334409, 3000334410, 3000336488, 3000337834, 3000342904, 3000342905, 3000342906, 3000342907, 3000342908, 3000344446, 3000344447, 3000344471, 3000344472, 3000344474, 3000346048, 3000346049, 3000346050, 3000346051, 3000346052, 3000348543, 3000348546, 3000348552, 3000348553, 3000349793, 3000349795, 3000349796, 3000349797, 3000352614, 3000352615, 3000352616, 3000352617, 3000353439, 3000353440

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1077-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1076-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-13
Z-1077-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-13

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)