Z-0436-2019Class I

QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i...

Name: Z-0436-2019 QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2018-10-25
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2018-10-25 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator... on 2018-10-25. FDA classified it as Class I and gives the reason as "There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0436-2019
Classification: Class I
Status: Terminated
Initiated: 2018-10-25
Posted: 2018-11-28
Terminated: 2020-06-05
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, GETTINGE, sent an "URGENT MEDICAL DEVICE RECALL" notification letters dated 10/25/18 to customers. The letters described the product, problem, and actions to be taken. The customers were instructed to do the following: -Please immediately examine your inventory to determine if you have any of the QUAD ROX-i Neonatal Oxygenator with the product codes/lot numbers listed in this notice. -If you wish to use the product, please remove and do not use the enclosed reducing screw adapter 1/4" x 3/16" (Ref. No. 70104.8593). -If you do not wish to use the product as packaged, please contact Maquet/Ge tinge Customer Support at +l (888) 627-8383 (press option 2, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to obtain instructions on returning the affected product for a full credit. Please note that this product is no longer being offered in the United States, and therefore product replacement is not available. -Please complete and sign the attached MEDICAL DEVICE RECALL- RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet/Ge tinge by e-mailing a scanned copy to [email protected] or by f axing the form to +l (800) 859-8371. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Maquet Cardiopulmonary /Ge tinge representative or call the Maquet Cardiopulmonary /Ge tinge Customer Support at +l (888) 627-8383 (press option 2, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Quantity in commerce: 490 total in US
Distribution: Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, IA, LA, NC, and TX and countries of: Canada, Argentina, Brazil, Chile, Colombia, Mexico, Uruguay, United Arab Emirates, Belgium, Switzerland, Germany, Egypt, Spain, France, United Kingdom, Ireland, Italy, Lebanon, Netherlands, Pakistan, Portugal, Reunion, Saudi Arabia, Sweden, South Africa, Poland, Serbia, Russia, Turkey, Ukraine, China, India, Japan, Republic of Korea (South Korea), Malaysia, Thailand, and Taiwan.
Product codes and lots: UDI: 04037691780139; Lots: 92212343, 92214685, 92225187

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0436-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0436-2019	Class I	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-28
Z-0437-2019	Class I	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-28

Product code DTZ

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)