Z-1661-2023Class II

Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA...

Name: Z-1661-2023 Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA...
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 Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445 on 2023-05-18. FDA classified it as Class II and gives the reason as "Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis...". 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-1661-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-18
Posted: 2023-05-30
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
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: Nationwide domestic distribution
Product codes and lots: Model Item No. UDI VKMO 10000-USA 701070441 4058863153889 VKMO 11000-USA 701070445 4058863153889 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1661-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1655-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-30
Z-1656-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-30
Z-1657-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-30
Z-1658-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-30
Z-1659-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-30
Z-1660-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-30
Z-1661-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-30
Z-1662-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-30

Product code DTZ

K102919Class IINeonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy Reservoir, Neonatal Venous HardsheMaquet Cardiopulmonary, AG / cleared 2011-03-11

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)