Product Wiki · Recalls · Health Canada — Medical Devices

Maquet Life Support Set and associated products (2015-12-07) — recall 55460

Health Canada — Medical Devices · Canada · 2016-06-13 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
55460
Date of alert
2016-06-13
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: In December 2014 Maquet Cardiopulmonary notified you via DYR 91 (FSN 2014-12-11) of the increased incidence of blood leakage from the gas outlet connector of the QUADROX-iD Adult and Small Adult products, including the HLS and PLS sets that contain related oxygenators of this product family. The increased leakage was due to a separation of a small number of the internal fibers from the polyurethane casting in the oxygenator. This separation resulted in the blood leakage that was the subject of the field safety notice. Since the release of this notification, we have been able to confirm the possible root cause that was described in the notification. Additionally, we have implemented and validated the necessary corrections that return the products to their original performance specifications. The correction necessary was the implementation of additional process controls during the production process of these fibers at our raw material supplier. The fibers produced under these increased process controls have now been delivered to Maquet Cardiopulmonary and used on the production of the finished oxygenator products.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/maquet-life-support-set-and-as

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