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Terminated

Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251

FDA Recall Z-1406-2023 · Posted 2023-04-19

Recalling FirmAvanos Medical, Inc.
Recall StatusTerminated
Product CodeKXF
Date Initiated2023-02-03
Date Terminated2024-08-19
Product Quantity5,475 cases

Reason for Recall

Incorrect expiration date.

Firm Action

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

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Germany, Netherlands, France, Switzerland, Great Britain, Israel, and India.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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