Product Wiki · Recalls · Health Canada — Medical Devices

ExactaMix EVA Container (2019-09-19) — recall 47895

Health Canada — Medical Devices · Canada · 2019-11-05 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
47895
Date of alert
2019-11-05
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Baxter Corporation has previously issued a voluntary product recall for certain lot numbers of the ExactaMix empty EVA bags due to the potential ability to leak once used for compounding. Baxter is expanding this recall to include additional lot numbers. There were 1612 complaints (5374 units) identified that are potentially related to this issue. 166 out of the 1612 complaints were of canadian origin. Please note that these 1612 complaints are for the 1622 lot numbers that are within scope of this issue, however, Canada only distributed 430 lots out of the affected 1622 lots. There have been no reports of serious injury associated with this issue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/exactamix-eva-container-2019-0

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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