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Recall Observatory FDA recall evidence

Device product

Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.

Z-0295-2016

October 23, 2015

Class II

Product summary

Firm
Fresenius Medical Care Renal Therapies Group, LLC
Event
Event 72484
Status
Terminated
Classification
Class II
Quantity
348 units
Official record key
device-enforcement:Z-0295-2016

Official wording

Reason: 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.

Code information: All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.