Recall Z-1406-2023 ยท KXF Applicator, Absorbent Tipped, Non-Sterile
Avanos Medical, Inc.
Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
| Date | Apr 19, 2023 (initiated Feb 3, 2023) |
| Status | Terminated |
| Reason | Incorrect expiration date. |
| Root cause | Under Investigation by 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. |
| Quantity | 5,475 cases |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Germany, Netherlands, France, Switzerland, Great Britain, Israel, and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.