QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 300

FDA device recall Z-0160-2013 · posted 2012-10-26 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular Us Sales, Llc

Reason for recall

It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,000) of units shipped.

Action taken

Maquet sent a Field Safety Notices and Confirmation Forms dated June 13, 2012 to all affected customers. A Follow-up communication dated July 20, 2012 was mailed to all affected US customers. The Field Safety Notice identifies the problem, affected product, risk factors and actions to be taken by the customer. Customers were instructed to complete the Confirmation form and return in the self-addressed prepaid envelop. For questions call 201-995-8968. Maquet issued an updated Field Safety Notice/Field Safety Notice Confirmation Form dated 2/14/13 via Fed Ex on 2/18/2013. Maquet sent out an Updated Field Safety Notice/field Safety Notice Confirmation Form dated 4/4/2013 in order to notify customers they would be providing safety clamps.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DTZ

Quantity affected

23,203 units

Distribution

US Nationwide Distribution

Date initiated

2012-06-12

Date posted

2012-10-26

Date terminated

2017-09-29

Location

Wayne, NJ

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