← Search recalls
FDA (Device enforcement)Recalled 2016-10-25closedclass ii

MED-EL Elektromedizinische Gereate, Gmbh: 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 use

Is my product affected?

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

  • UPC 09008737333720
  • UPC 09008737333744
  • UPC 09008737333751
  • UPC 09008737333768
  • UPC 09008737333775
  • UPC 09008737333782

Check against the official notice below — it lists the full affected range.

What happened

MED-EL Elektromedizinische Geräte, GmbH is recalling the SONNET Mini Battery Pack Cable due to a manufacturing defect in which the compartment lock was not firmly welded to the housing. A total of 538 units were affected and distributed worldwide, including in the United States in California, North Carolina, and Texas, as well as in Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay.

The recalled units include six different color variants (anthracite 50, ebony 50, black 50, white 50, beige 50, and grey 50), each with specific part numbers ranging from 32291 to 32296 and corresponding kit numbers and UDI codes. The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing. 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, Turkey, United Kingdom, and Uruguay. Quantity: 538 units Lot/code info: Part No. 32291, Kit 33372, Kit UDI - Primary ID: 09008737333720 (anthracite 50); Part No. 32292, Kit 33374, Kit UDI - Primary ID: 09008737333744 (ebony 50); Part No. 32293, Kit 33375, Kit UDI - Primary ID: 09008737333751 (black 50); Part No. 32294, Kit 33376, Kit UDI - Primary ID: 09008737333768 (white 50); Part No. 32295, Kit 33377, Kit UDI - Primary ID: 09008737333775 (beige 50) and Part No. 32296, Kit 33378, Kit UDI - Primary ID: 09008737333782 (grey 50).

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

All FDA (Device enforcement) recalls

Hurt by this product? Start a free Case Check

ProductRisk is not a law firm and does not provide legal services or legal advice. ProductRisk is a free consumer product-safety information service operated by Plaintify, Inc., a technology company. If you ask to be connected with a law firm, any legal services are provided by that firm — not by ProductRisk or Plaintify.

Privacy · Plaintify