Product Wiki · Recalls · Health Canada — Medical Devices

Revolve System — recall 44490

Health Canada — Medical Devices · Canada · 2017-09-05 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 44490
Date of alert: 2017-09-05
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: This recall has been initiated due to the presence of bacterial endotoxins levels for some revolve units are above the acceptable limits as defined in the standard, USP ("medical devices - bacterial endotoxin and pyrogen tests"). The issue was self-identified/confirmed on May 4, 2017.161>

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/revolve-system-0

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Revolve System — recall 44490

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