Recall Z-0792-2020 ยท LXB Hearing Aid, Bone Conduction
Cochlear Americas Inc.
Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
| Date | Dec 18, 2018 |
| Status | Terminated |
| Reason | Product was packaged with the Incorrect tamper proof battery door. |
| Root cause | Packaging process control |
| Action | 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 |
| 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) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142907 | Baha 5 Sound Processor Cochlear Americas, Mar 25, 2015 |