Maquet Oxygenators (various) (2014-12-29)

Starting date:

December 29, 2014

Posting date:

April 29, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-52433

• Reason
• Affected products

Recalled Products

A. Standard Pump Pack Bioline

B. Heart Lung Pack Bioline

C. Permanent Life Support Set

D. Quadrox-ID Adult Oxygenator (with Bioline)

E. Quadrox-ID Adult Oxygenator (with Softline)

Reason

Maquet Cardiopulmonary has been receiving complaints for the Quadrox-ID adult and Quadrox-ID small adult Diffusion Membrane Oxygenators, as well as the oxygenators contained in HLS and PLS sets (due to the similarities of the oxygenator contained in these sets), regarding blood leaking from the gas outlet connector (or the area at the lowest part of the oxygenator), and has noticed an increase in the frequency of these reports.

Affected products