Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
FDA Recall #Z-0792-2020 — Class II — December 18, 2018
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.
Recalling Firm
Cochlear Americas Inc. — Centennial, CO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
50 units
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)
Code Information
Part Number: P1129017 UDI Number: 09321502041096 Lot Number: COH1253733
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated