Baxter recalls some lots of Revaclear dialyzers due to leaks

Baxter Healthcare Corporation sent letters to dialysis providers on May 31 saying it was voluntarily recalling certain lots of its Revaclear 300 and 400 model hemodialyzers due to blood leaks. The company said in the letter there has been one report of a serious injury “possibly associated with this issue.”

The two-page letter, signed by Merle Goddard, senior director of quality at Baxter Healthcare Corporation, described the problem as the “potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.” Baxter said it has notified the FDA of the recall. The affected lots were distributed between March 6 and May 24 in the United States.

Goddard said in the letter that the issue had been isolated to one production line at the company’s manufacturing facility and “corrective actions have been implemented to resolve the issue in newly manufactured Revaclear Dialyzers,” she said. Dialyzers from lots not listed can be used.

Baxter Healthcare Center for Service will provide a credit for returned dialyzers. For more information, call 888-229-0001.

Any adverse reactions or quality problems experienced with the dialyzers can be reported by calling Baxter Product Surveillance at 1-800-437-5176 or by emailing Baxter at corporate_product_complaints_round_lake@baxter.com.

Reporting problems with the dialyzers can also be done through the FDA MedWatch Adverse Event Reporting Program, online at www.fda.gov/medwatch/report.

The affected lot numbers and expiration dates provided in the letter for recalled Revaclear 300 dialyzers include the following:

Lot number/Expiration date

C419105401 ; 2/28/2022

C419105501 ; 3/2/2022

C419105601 ; 3/3/2022

C419105701 ; 3/4/2022

C419105801 ; 3/5/2022

C419105901 ; 3/6/2022

C419106001 ; 3/7/2022

C419106101 ; 3/8/2022

C419106201 ; 3/9/2022

C419106301 ; 3/10/2022

C419106401 ; 3/11/2022

C419106501 ; 3/12/2022

C419106601 ; 3/13/2022

C419106701 ; 3/15/2022

C419106801 ; 3/16/2022

C419106901 ; 3/17/2022

C419107001 ; 3/18/2022

C419107101 ; 3/19/2022

C419107201 ; 3/20/2022

C419107301 ; 3/21/2022

C419107401 ; 3/22/2022

C419107501 ; 3/23/2022

C419107601 ; 3/25/2022

C419107701 ; 3/26/2022

C419107801 ; 3/27/2022

C419107901 ; 3/28/2022

C419108001 ; 3/29/2022

C419108101 ; 3/30/2022

C419108201 ; 4/1/2022

C419108301 ; 4/2/2022

C419108401 ; 4/3/2022

C419108501 ; 4/5/2022

C419108601 ; 4/6/2022

C419108701 ; 4/7/2022

C419108801 ; 4/8/2022

C419108901 ; 4/9/2022

C419109001 ; 4/10/2022

C419109101 ; 4/11/2022

C419109201 ; 4/12/2022

C419109301 ; 4/14/2022

C419109401 ; 4/18/2019

C419109501 ; 4/16/2022

C419109601 ; 4/17/2022

C419109801 ; 4/19/2022

C419110001 ; 4/21/2022

C419110101 ; 4/22/2022

C419110201 ; 4/23/2022

C419110301 ; 4/24/2022

C419110401 ; 4/25/2022

C419110501 ; 4/26/2022

C419110601 ; 4/27/2022

C419110701 ; 4/28/2022

C419110801 ; 4/29/2022

C419111001 ; 5/1/2022

C419111101 ; 5/2/2022

C419111301 ; 5/4/2022

C419111501 ; 5/6/2022

C419111601 ; 5/7/2022

C419111701 ; 5/8/2022

Affected lot numbers and expiration dates for recalled Revaclear 400 dialyzers include:

C419205101 ; 2/24/2022

C419205201 ; 2/26/2022

C419205301 ; 2/27/2022

-by Mark E. Neumann

Reference:

Goddard M. Urgent product recall to dialysis providers, letter, May 31, 2019.

Baxter Healthcare Corporation sent letters to dialysis providers on May 31 saying it was voluntarily recalling certain lots of its Revaclear 300 and 400 model hemodialyzers due to blood leaks. The company said in the letter there has been one report of a serious injury “possibly associated with this issue.”

The two-page letter, signed by Merle Goddard, senior director of quality at Baxter Healthcare Corporation, described the problem as the “potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.” Baxter said it has notified the FDA of the recall. The affected lots were distributed between March 6 and May 24 in the United States.

Goddard said in the letter that the issue had been isolated to one production line at the company’s manufacturing facility and “corrective actions have been implemented to resolve the issue in newly manufactured Revaclear Dialyzers,” she said. Dialyzers from lots not listed can be used.

Baxter Healthcare Center for Service will provide a credit for returned dialyzers. For more information, call 888-229-0001.

Any adverse reactions or quality problems experienced with the dialyzers can be reported by calling Baxter Product Surveillance at 1-800-437-5176 or by emailing Baxter at corporate_product_complaints_round_lake@baxter.com.

Reporting problems with the dialyzers can also be done through the FDA MedWatch Adverse Event Reporting Program, online at www.fda.gov/medwatch/report.

The affected lot numbers and expiration dates provided in the letter for recalled Revaclear 300 dialyzers include the following:

Lot number/Expiration date

C419105401 ; 2/28/2022

C419105501 ; 3/2/2022

C419105601 ; 3/3/2022

C419105701 ; 3/4/2022

C419105801 ; 3/5/2022

C419105901 ; 3/6/2022

C419106001 ; 3/7/2022

C419106101 ; 3/8/2022

C419106201 ; 3/9/2022

C419106301 ; 3/10/2022

C419106401 ; 3/11/2022

C419106501 ; 3/12/2022

C419106601 ; 3/13/2022

C419106701 ; 3/15/2022

C419106801 ; 3/16/2022

C419106901 ; 3/17/2022

C419107001 ; 3/18/2022

C419107101 ; 3/19/2022

C419107201 ; 3/20/2022

C419107301 ; 3/21/2022

C419107401 ; 3/22/2022

C419107501 ; 3/23/2022

C419107601 ; 3/25/2022

C419107701 ; 3/26/2022

C419107801 ; 3/27/2022

C419107901 ; 3/28/2022

C419108001 ; 3/29/2022

C419108101 ; 3/30/2022

C419108201 ; 4/1/2022

C419108301 ; 4/2/2022

C419108401 ; 4/3/2022

C419108501 ; 4/5/2022

C419108601 ; 4/6/2022

C419108701 ; 4/7/2022

C419108801 ; 4/8/2022

C419108901 ; 4/9/2022

C419109001 ; 4/10/2022

C419109101 ; 4/11/2022

C419109201 ; 4/12/2022

C419109301 ; 4/14/2022

C419109401 ; 4/18/2019

C419109501 ; 4/16/2022

C419109601 ; 4/17/2022

C419109801 ; 4/19/2022

C419110001 ; 4/21/2022

C419110101 ; 4/22/2022

C419110201 ; 4/23/2022

C419110301 ; 4/24/2022

C419110401 ; 4/25/2022

C419110501 ; 4/26/2022

C419110601 ; 4/27/2022

C419110701 ; 4/28/2022

C419110801 ; 4/29/2022

C419111001 ; 5/1/2022

C419111101 ; 5/2/2022

C419111301 ; 5/4/2022

C419111501 ; 5/6/2022

C419111601 ; 5/7/2022

C419111701 ; 5/8/2022

Affected lot numbers and expiration dates for recalled Revaclear 400 dialyzers include:

C419205101 ; 2/24/2022

C419205201 ; 2/26/2022

C419205301 ; 2/27/2022

-by Mark E. Neumann

Reference:

Goddard M. Urgent product recall to dialysis providers, letter, May 31, 2019.