Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0098-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 1, 2020

Date Posted: October 21, 2020

Recall Number: Z-0098-2021

Event ID: 86410

Reason for Recall:

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.

Status: Terminated

Product Quantity: 15 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated