Certain lots of a Baxter International dialyzer have been voluntarily recalled. The Deerfield, IL-based company reported one “serious injury” possibly associated with the issue.
The Revaclear Dialyzer 300 and 400 model lots were being recalled due to blood leaks. One product line at the manufacturing facility was traced as the problem area and corrections were implemented, according to a two-page letter from Merle Goddard, senior director of quality at Baxter HealthCare.
For more information, contact Baxter at 888-229-0001. Baxter Healthcare Center for Service is providing a credit for returned dialyzers.
Any adverse reactions or quality problems experienced with the dialyzers may be reported to Baxter Product Surveillance at 800-437-5176 or by emailing Baxter at corporate_product_complaints_round_lake@baxter.com.
Problems with the dialyzers may also be reported through the FDA MedWatch Adverse Event Reporting Program at www.fda.gov/medwatch/report.
As of early June, the Optiflux F160NR Capillary High Flux hemodialyzer from Fresenius was listed as being under an open recall status for lot numbers 18HU06016, 18HU06017, 18HU06018 and 18HU06019. The problem was reported to the FDA as “potential for external blood leaks from the dialyzer header.” Customers with questions may contact Medical Information and Communications at 855-616-2309 or at www.fresenius-medinfo.com.
