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

Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147 — recall Z-0295-2016

U.S. FDA — Device Enforcement · United States · 2015-10-23 · Class II

As described by U.S. FDA — Device Enforcement: Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0295-2016
Date of alert
2015-10-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Fresenius Medical Care Renal Therapies Group, LLC
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribution.
Reported risk: Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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