Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1364-2022 — AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US)

U.S. FDA — Device Enforcement · United States · 2021-08-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1364-2022
Date of alert
2021-08-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Fresenius Medical Care Holdings, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04251285200227
Reported risk: AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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