Product Wiki · Recalls · Health Canada — Medical Devices

Cellex Photopheresis System (2018-08-10) — recall 58362

Health Canada — Medical Devices · Canada · 2018-09-07 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
58362
Date of alert
2018-09-07
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Mallinckrodt has received reports of thromboembolic events associated with the use of the THERAKOS CELLEX Photopheresis System in the treatment of Graft versus Host Disease (GvHD). Patients with GvHD have an increased risk of thromboembolic events. The Caution Statement will be updated in the device Operator's Manual section, titled "Anticoagulation."
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cellex-photopheresis-system-20

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