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Health Canada Medical devices

Prismaflex Sets

Issued September 23, 2022
Issue
Baxter Corporation is issuing an urgent medical device correction for the Prismaflex sets listed. The current Prismaflex set IFU is a single booklet containing 27 translated languages, and the following products include a mistranslation in the Estonian (EESTI) IFU. The mistranslation indicates contradictory information related to the patient body weight restrictions. Recall start date: September 15, 2022
Hazard description
Labelling and packaging
Product
Product name
Prismaflex Sets
Reference
ID
RA-64581