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