FDA recall Z-1406-2023

Avanos Medical, Inc. · Class II · device

Product

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

Reason for recall

Incorrect expiration date.

Distribution

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

Key facts

Status
Terminated
Initiation date
2023-02-03
Report date
2023-04-26
Termination date
2024-08-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1406-2023