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Recall Observatory FDA recall evidence

Device product

Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)

Z-0792-2020

December 18, 2018

Class II

Product summary

Firm
Cochlear Americas Inc.
Event
Event 83970
Status
Terminated
Classification
Class II
Quantity
50 units
Official record key
device-enforcement:Z-0792-2020

Official wording

Reason: Product was packaged with the Incorrect tamper proof battery door.

Code information: Part Number: P1129017 UDI Number: 09321502041096 Lot Number: COH1253733

Distribution pattern: 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)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product was packaged with the Incorrect tamper proof battery door.