FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular Us Sales, Llc: 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.
- Recall number
- Z-0689-2012
- 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.
- Status
- Terminated
- Initiated
- 2011-09-22
- Posted
- 2012-01-11
- Terminated
- 2014-09-18
- Reason
- There are reports of leakage in the Leuer connector of the blood outflow connector of the Quadrox-iD pediatric oygenator.
- 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: whitney.torning@maquet.com. Should you have any questions or concerns, please do not hesitate to contact MAQUET Customer Service at 800-777-4222.
- Quantity
- 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.
- Lot, serial or model codes
- 510(k) numbers: 1<100278 (Bioline coated) Device Listing No. 0098004 BEQ-HMOD 30000 70064002-28 units 70064004-140 units
- 510(k) numbers
- ["K100278"]
- PMA numbers
- not on file
- Product code
- DTZ
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28