Recall Z-0098-2021— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0098-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-01

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2020-09-01, terminated 2021-01-20. It names one FDA 510(k) clearance: K133829. 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. 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..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-09-01
Terminated: 2021-01-20
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K133829 — AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HFVivonic GmbH·cleared 2014-04-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.