Cellex Photopheresis System (2018-08-10)

Starting date:

August 10, 2018

Posting date:

September 7, 2018

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-67696

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  Reason
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  Affected products

Affected products

Cellex Photopheresis System

Reason

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."

Affected products