Reported Mar 8, 2017 · Terminated

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

MED-EL Elektromedizinische Gereate, GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MED-EL Elektromedizinische Gereate, Gmbh · Furstenweg 77a · Innsbruck, N/A · N/A

SONNET
Mini Battery Pack CableProduct UsageThe 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

Lot codes and dates: 5 of 5 products
Products covered by this recall
Model / number Barcodes Product as published
32291 09008737333720 Kit 33372, Kit UDI - Primary ID: 09008737333720 (anthracite 50)
32292 09008737333744 Kit 33374, Kit UDI - Primary ID: 09008737333744 (ebony 50)
32293 09008737333751 Kit 33375, Kit UDI - Primary ID: 09008737333751 (black 50)
32294 09008737333768 Kit 33376, Kit UDI - Primary ID: 09008737333768 (white 50)
32296 0900873733377509008737333782 Part No. 32295, Kit 33377, Kit UDI - Primary ID: 09008737333775 (beige 50) and , Kit 33378, Kit UDI - Primary ID: 09008737333782 (grey 50).
Amount recalled: 538 units

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Model / number	Barcodes	Product as published
`32291`	`09008737333720`	Kit 33372, Kit UDI - Primary ID: 09008737333720 (anthracite 50)
`32292`	`09008737333744`	Kit 33374, Kit UDI - Primary ID: 09008737333744 (ebony 50)
`32293`	`09008737333751`	Kit 33375, Kit UDI - Primary ID: 09008737333751 (black 50)
`32294`	`09008737333768`	Kit 33376, Kit UDI - Primary ID: 09008737333768 (white 50)
`32296`	`0900873733377509008737333782`	Part No. 32295, Kit 33377, Kit UDI - Primary ID: 09008737333775 (beige 50) and , Kit 33378, Kit UDI - Primary ID: 09008737333782 (grey 50).