FDA recall Z-0792-2020

Cochlear Americas Inc. · Class II · device

Product

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

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)

Key facts

Status
Terminated
Initiation date
2018-12-18
Report date
2020-01-15
Termination date
2021-01-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Centennial, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0792-2020