Revaclear 400 Dialyzer; Revaclear 300 Dialyzer
Brand(s)
Last updated
Summary
Product
Revaclear 400 Dialyzer; Revaclear 300 Dialyzer
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Revaclear 400 Dialyzer; Revaclear 300 Dialyzer | More than 10 numbers, contact manufacturer. | REVACLEAR 400 REVACLEAR 300 |
Issue
Baxter Corporation is communicating two separate, but associated, issues related to Revaclear dialyzers. The first issue is linked to reports of internal blood leaks being caused by a twisted gasket in the dialyzer, prompting Baxter to recall the impacted lots. The second issue is linked to reports of polyurethane displacement in the dialyzer, prompting Baxter to issue a safety alert for the impacted lots.
Recall start date: November 24, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Gambro Renal Products Inc.
1101 Jeter Avenue, Opelika, Alabama, United States, 36801
Published by
Health Canada
Audience
General public
Healthcare
Recall class
Type II
Identification number
RA-72234
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