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SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack,

FDA device recall Z-1395-2017 · posted 2017-03-02 · Terminated

Recall details

Recalling firm
MED-EL Elektromedizinische Gereate, Gmbh
Reason for recall
Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.
Action taken
MED-EL is notifying all consignees to whom affected products have been directly shipped by Headquarters (based on first delivery shipment records) on 10/25/2016.
Root cause
Device Design
Status
Terminated
Product code
ISM
Quantity affected
538 units
Distribution
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, Tu
Date initiated
2016-10-25
Date posted
2017-03-02
Date terminated
2017-04-04
Location
Innsbruck, Austria

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