Product Wiki · Recalls · Health Canada — Medical Devices

Trima Accel Platelet and Multiplasma Sets (2019-12-19) — recall 63179

Health Canada — Medical Devices · Canada · 2020-02-28 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
63179
Date of alert
2020-02-28
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Complaints have been received by Terumo BCT for pressure test error alerts that are associated with inflation and pressurization of the sample bag. A new sample bag line clamp was introduced in early 2019 to mitigate the issue. There has been an increase in the frequency of complaints for the issue since the introduction of the new clamp, including one incident in which air was infused into a donor. Root cause investigation identified two potential causes for the failure of the new sidewall clamp.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/trima-accel-platelet-and-multi

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