MED-EL Elektromedizinische Gereate, Gmbh recalls SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack…

Recall date

October 25, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1395-2017

FDA classification

Class II

Brand / firm

MED-EL Elektromedizinische Gereate, Gmbh

Sold / distributed

Worldwide Distribution - US Nationwide in the states of CA, NC and TX; and the countries of Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay.

Why it was recalled

Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.