Z-0689-2012

MAQUET QUADROX iD PEDIATRIC -OXYGENATOR: BEQ-HMOD 3000; Made In Germany The diffusion membrane oxygenator...

Name: Z-0689-2012 MAQUET QUADROX iD PEDIATRIC -OXYGENATOR: BEQ-HMOD 3000; Made In Germany The diffusion membrane oxygenator...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2011-09-22
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2011-09-22 / Terminated / root cause: design

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of MAQUET QUADROX iD PEDIATRIC -OXYGENATOR: BEQ-HMOD 3000; Made In Germany The diffusion membrane oxygenator Quadrox iD pediatric is intended for use in an... on 2011-09-22. The reason FDA records is "There are reports of leakage in the Leuer connector of the blood outflow connector of the Quadrox-iD pediatric oygenator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0689-2012
Status: Terminated
Initiated: 2011-09-22
Posted: 2012-01-11
Terminated: 2014-09-18
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: MAQUET QUADROX iD PEDIATRIC -OXYGENATOR: BEQ-HMOD 3000; Made In Germany The diffusion membrane oxygenator Quadrox iD pediatric is intended for use in an extracorporeal perfusion system. The oxygenator is designed for a blood flow rate of 0.2 -2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature.The utilization period for this device is restricted to six hours.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: There are reports of leakage in the Leuer connector of the blood outflow connector of the Quadrox-iD pediatric oygenator.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Maquet Getinge Group, sent an "PRODUCT RECALL URGENT-MEDICAL DEVICE REMOVAL ACTION" letter dated September 22, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed tocheck their remaining inventory; remove product immediately to prevent use; remove the boxes or individually pouched oxygenators in a secure area of their facility and notify their MAQUET representative (a representative will physically remove the recalled product and replenish the removed units); and complete and return the enclosed Product Removal Disposition Form via fax to: (973)-807-9210 or email: [email protected]. Should you have any questions or concerns, please do not hesitate to contact MAQUET Customer Service at 800-777-4222.
Quantity in commerce: 168 units
Distribution: Nationwide distribution: AL, CA, DE, DC, FL, GA, HI, IL, IN, LA, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, and TX.
Product codes and lots: 510(k) numbers: 1<100278 (Bioline coated) Device Listing No. 0098004 BEQ-HMOD 30000 70064002-28 units 70064004-140 units

Product code DTZ

K100278Class IIQuadrox-Id Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models Be-Hmod 30000-USA, Beq-Hmod 30000-USAMaquet Cardiopulmonary, AG / cleared 2010-04-30

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)