Z-0792-2020 Class II Terminated
FDA device recall Z-0792-2020 was initiated by Cochlear Americas Inc. on December 18, 2018 and is designated Class II. Reason for recall: Product was packaged with the Incorrect tamper proof battery door. The recall status is terminated (terminated January 28, 2021). Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2020
- Initiation Date
- December 18, 2018
- Termination Date
- January 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
Reason for Recall
Product was packaged with the Incorrect tamper proof battery door.
Distribution Pattern
Domestic: CA, FL, IL, IN, MA, MO, NY, SD, TN, and TX OUS Regions; Asia Pacific (APAC), and Europe, The Middle East and Africa (EMEA)
Code Information
Part Number: P1129017 UDI Number: 09321502041096 Lot Number: COH1253733