Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
FDA device recall Z-1406-2023 · posted 2023-04-19 · Terminated
Recall details
- Recalling firm
- Avanos Medical, Inc.
- Reason for recall
- Incorrect expiration date.
- Action taken
- Avanos issued an Urgent Medical Device Recall notice to its consignees on 02/03/2023 by US mail. The notice explained the issue and requested the following: 1) Use the products prior to their 5-year expiration date; 2) Complete and return the Acknowledgement Form via email; and 3) Circulate the notice to all departments and satellite facilities who may have received the product.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- KXF
- Quantity affected
- 5,475 cases
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Germany, Netherlands, France, Switzerland, Great Britain, Israel, and India.
- Date initiated
- 2023-02-03
- Date posted
- 2023-04-19
- Date terminated
- 2024-08-19
- Location
- Alpharetta, GA
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