Product Wiki · Recalls · Health Canada — Medical Devices

Plasma Collection System 2 & PCS2 (2020-04-09) — recall 61280

Health Canada — Medical Devices · Canada · 2020-05-22 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
61280
Date of alert
2020-05-22
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: This action is a correction to the device labeling (user manual). The device itself is not defective. We have identified that the calculation for volume of anticoagulant (AC) in the apheresis plasma product provided in revision AA of the PCS2 user manual does not account for approximately 9ml of AC that is present in the disposable set after priming the tubing at the start of a procedure.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/plasma-collection-system-2-pcs

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