Fresenius Dry Acid Dissolution Units

• 2 recalls, same reason

  • Terminated Z-0295-2016 FDA Class II ·initiated 23 Oct 2015
  • Terminated Z-0296-2016 FDA Class II ·initiated 23 Oct 2015

  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.

510(k) Number

K131611 ↗

FDA Product Code

KPO

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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