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Terminated

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.

FDA Recall Z-0689-2012 · Posted 2012-01-11

Recalling FirmMaquet Cardiovascular Us Sales, Llc
Recall StatusTerminated
Product CodeDTZ
Date Initiated2011-09-22
Date Terminated2014-09-18
Product Quantity168 units

Reason for Recall

There are reports of leakage in the Leuer connector of the blood outflow connector of the Quadrox-iD pediatric oygenator.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100278QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USAMaquet Cardiopulmonary, AG · 2010-04-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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