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

FDA device recall Z-0689-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular Us Sales, Llc

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

DTZ

Quantity affected

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.

Date initiated

2011-09-22

Date posted

2012-01-11

Date terminated

2014-09-18

Location

Wayne, NJ

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