Recalls / —

—#183655

Product

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

FDA product code

FIP — Subsystem, Water Purification

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K133829

Affected lot / code info

9BDS1515 08D51544 OBDS1596 OBPS2864 9BDS1529 OBDS1545 OBPS2799 OBPS2884 9BPS2735 OBDS1551 OBPS2800 OBPS2903 9BPS2767 08D51590 OBPS2810

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Fresenius Medical Care Holdings, Inc.

Address

920 Winter St, Bld 950, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern

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

Timeline

Recall initiated

2020-09-01

Terminated

2021-01-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #183655. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.