Health product recall

Prismaflex Sets

Brand(s)
Prismaflex Sets
Last updated

Summary

Product
Prismaflex Sets
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Prismaflex Hf20 Set

All lots.

PRISMAFLEX HF20 SET

Prismaflex Hf1000 Set

All lots.

PRISMAFLEX HF1000

Prismaflex St60 Set, Prismaflex St100 Set, Prismaflex St150 Set

All lots.

PRISMAFLEX ST150 SET
PRISMAFLEX ST100 SET
PRISMAFLEX ST60 SET

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies

Gambro Industries

7 Avenue Lionel-Terray, Meyzieu, France, 69883

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64581

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