Product Wiki · Recalls · Health Canada — Medical Devices

LEVEL 1® Fast Flow and Irrigation Fluid Warming Systems (2021-08-11) — recall 62796

Health Canada — Medical Devices · Canada · 2021-08-27 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62796
Date of alert
2021-08-27
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The FDA has recently been in communication with multiple medical device manufacturers concerning the potential for aluminum leaching from fluid warming systems. Many of these devices were developed and approved by the agency prior to the availability of modern analytical technology used to detect aluminum at the threshold limits present in the regulations. The FDA has had several communications with Smiths Medical regarding the potential for aluminum leaching from our level 1 fast flow fluid warming systems and normoflo products. While published studies conducted by Smiths Medical have been presented to them indicating that under normal use these devices meet acceptable limits in regard to aluminum leaching, they disagreed with that assessment and requested that a draft recall notification package be submitted. For consistency, we are notifying all geographies where these products are marketed of this advisory notice developed in response to the FDA request.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/level-1r-fast-flow-and-irrigat

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