Recall Z-0792-2020— Cochlear Americas Inc.

Name: FDA recall Z-0792-2020
Creator: U.S. Food and Drug Administration
Published: 2018-12-18

Class II · Terminated

Class II FDA medical device recall by Cochlear Americas Inc., initiated 2018-12-18, terminated 2021-01-28. It names one FDA 510(k) clearance: K142907. Product: Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.). Reason: Product was packaged with the Incorrect tamper proof battery door..

Recalling firm: Cochlear Americas Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-12-18
Terminated: 2021-01-28
Firm location: Centennial, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K142907 — Baha 5 Sound ProcessorCochlear Americas·cleared 2015-03-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.