Revaclear 400 Dialyzer; Revaclear 300 Dialyzer
Brand(s)
Summary
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 |
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
Gambro Renal Products Inc.
1101 Jeter Avenue, Opelika, Alabama, United States, 36801
Get notified
Receive notifications for new and updated recalls and alerts by category.