FDA Recall Terminated

AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1 AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part Number: 24-2000-0

Recall: Z-0098-2021 · Initiated September 1, 2020

Recall

Recall Number: Z-0098-2021
Event Number: 86410
Firm: Fresenius Medical Care Holdings, Inc.
FEI Number: 3001451489
Product Code: FIP
Status: Terminated
Root Cause: Process control
Initiated: September 1, 2020
Terminated: January 20, 2021
Address: 920 Winter St, Bld 950, Waltham, MA, 02451-1521

Description

Reason

Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the products, potentially resulting in electrical shock to the Biomed Technician or clinic staff.

Action

Fresenius Medical Care issued letter dated 9/1/20 stating reason for recall, health risk and action to take: A Fresenius Medical Care Renal Therapies Group Water Systems Service Specialist will be contacting you to schedule an appointment to check the connection and replace if necessary. In the meantime, we ask that you do not perform any repairs or maintenance on the machine and wait for your scheduled service date. For questions or concerns or if you need service prior to your scheduled service date, please contact Technical Support Services at 888-553-1109.

Distribution

US distribution to DE, NC, OK, PA, and TX.

Quantity

15 units