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U.S. Department of Health and Human Services

Class 2 Device Recall WIDEX BABY440

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 Class 2 Device Recall WIDEX BABY440see related information
Date Initiated by FirmAugust 31, 2018
Create DateOctober 10, 2018
Recall Status1 Terminated 3 on December 21, 2018
Recall NumberZ-0094-2019
Recall Event ID 81085
Product Classification Hearing aid, air conduction - Product Code ESD
ProductWidex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.
Code Information Serial numbers 024569 and 024550
FEI Number 3003557127
Recalling Firm/
Manufacturer		 Widex A/S
Nymollevej 6
Lynge Denmark
Manufacturer Reason
for Recall		The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.
FDA Determined
Cause 2		Employee error
ActionThe firm, Widex, sent an "Urgent Medical Device Correction Letter" dated 8/28/18 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: a) Investigate, whether your childs BABY440 hearing aid is mounted with the correct battery drawer. Please refer to the attachment How to determine if correct battery drawer is mounted. b) If affirmative, return the product to the hearing care professional, where you bought the hearing aid, to have the tamper-resistant battery drawer mounted. If you have any questions, contact Director, Global Regulatory Affairs at 0045 44 35 57 71 or email to: krpe@widex.com.
Quantity in Commerce2
DistributionUS Distribution to states of: GA and NY.
Total Product Life CycleTPLC 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.
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