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U.S. Department of Health and Human Services

Class 2 Device Recall Baha 5 Tamper Proof Battery Door (3 pcs)

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  Class 2 Device Recall Baha 5 Tamper Proof Battery Door (3 pcs) see related information
Date Initiated by Firm December 18, 2018
Create Date January 24, 2020
Recall Status1 Terminated 3 on January 28, 2021
Recall Number Z-0792-2020
Recall Event ID 83970
510(K)Number K142907  
Product Classification Hearing aid, bone conduction - Product Code LXB
Product Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
Code Information Part Number: P1129017 UDI Number: 09321502041096 Lot Number: COH1253733
Recalling Firm/
Manufacturer		 Cochlear Americas Inc.
13059 E Peakview Ave
Centennial CO 80111-6511
For Additional Information Contact Edward Wertepny
303-264-2163
Manufacturer Reason
for Recall		 Product was packaged with the Incorrect tamper proof battery door.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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)
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LXB and Original Applicant = COCHLEAR AMERICAS
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