Z-1641-2023Class II

QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO...

Name: Z-1641-2023 QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO...
Creator: Maquet Medical Systems USA
Published: 2023-05-18
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2023-05-18 / Open, Classified / root cause: packaging

FDA source

Maquet Medical Systems USA began a recall of QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388 on 2023-05-18. FDA classified it as Class II and gives the reason as "1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may...". 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-1641-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-18
Posted: 2023-05-26
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Product code: DTR Heat-Exchanger, Cardiopulmonary Bypass
Reason for recall: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Root cause tag: packaging
FDA root cause: Pending
Action: On May 18, 2023, the firm notified customers of the recall via an Urgent Medical Device Removal letter. Actions to be taken by the customer: If an affected device is already in use, please use according to normal practices. Monitor the patient for signs and symptoms of inflammation, infection, sepsis, and ischemia. If detected, treat according to clinical protocols. Please remove any affected product in inventory from areas of use. Unopened and unexpired affected product is eligible for credit upon return. Product Return: Please contact Getinge Customer Service at 1-888-943-8872 option 2 between the hours of 6:00 AM and 5:00 PM Pacific Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. Distributors who have shipped affected products to customers should forward the notification to customers' attention for appropriate action. Maquet Cardiopulmonary GmbH is working with all possible urgency on the redesign and revalidation of a packaging solution, which is anticipated to be available by Q4 2023.
Quantity in commerce: 0 (US)
Distribution: Domestic distribution nationwide.
Product codes and lots: Model Item No. UDI-DI HMO 30000-USA 701070384 4058863153681 HMO 31000-USA 701070388 4058863154299 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1641-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1634-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-26
Z-1635-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-26
Z-1636-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-26
Z-1637-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-26
Z-1638-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-26
Z-1639-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-26
Z-1640-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-26
Z-1641-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-26
Z-1642-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-26
Z-1643-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-26

Product code DTR

K103191Class IIQuadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline / Bioline CoatingMaquet Cardiopulmonary, AG / cleared 2011-03-08

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)