Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
This recall has been terminated (originally issued December 18, 2018).
- Company
- Cochlear Americas Inc.
- Recall Initiated
- December 18, 2018
- Terminated
- January 28, 2021
- Recall Number
- Z-0792-2020
- Quantity
- 50 units
- Firm Location
- Centennial, CO
- Official Source
- View on FDA website ↗
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)
Lot / Code Info
Part Number: P1129017 UDI Number: 09321502041096 Lot Number: COH1253733
Root Cause
Packaging process control
Action Taken
On 12/18/2018, the firm sent a "MEDICAL DEVICE RECALL NOTICE" to affected customers via telephone or email informing them of a packaging error for a specific lot (LOT # COH1253733) Tamper Proof Battery Doors. Customers are instructed to: 1-Examine their inventory and if they should have any of the affected product in their possession to carefully verify that they are the tamper proof version, and if in doubt about the functionality or identity - to scrap the item and to inform the Recalling Firm by filling out and return the Response Form. The Recalling Firm will arrange to send replacement product. 2-If customers receive complaints or queries from their users about "loose battery doors" or similar, to please advise the user to check the functionality according to the Recalling Fir's instructions "Baha 5 User Manual" and to scrap and replace as necessary. 3-To identify customers or users to whom they have distributed battery doors from the affected lot and to provide contact information to the Recalling Firm. The Recalling Firm will make contact, explain the issue, and send replacement product directly to them if necessary. NOTE: If you (the customer) do not have specific records showing with customers may have received affected product, they are to consider providing the Recalling Firm with a list of all customers that received a Baha 5 system between Sept. 1, 2018 and Dec. 18, 2018 so that the Recalling Firm may contact them. For any questions about the product recall customers can contact the Recalling Firm's Quality Department at 303-264-2163.