Class II Recall

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

Summary

The FDA issued a Class II for Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, by Avanos Medical, Inc.. Reason: Incorrect expiration date..

Details

Source

Device Recall

External ID

Z-1406-2023

Action Date

2023-04-26

Status

Terminated

Product Description

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

Lot/Code Info: a) 12241, Lot Numbers: 20067528, 20069614, 20077132, 20079287, 20079286, 20079285, 20079284, 20079283, 20079282, 20082126, 20082118, 20082119, 20082120, 20082121, 20082122, 20086314; b) 12243, Lot Numbers: 20050262, 20050263, 20050261, 20050264, 20050265, 20058683, 20058689, 20061145, 20061947, 20061946, 20062596, 20062597, 20063681, 20063682, 20064346, 20064347, 20064363, 20064364, 20064656, 20064657, 20065662, 20065663, 20065667, 20065668, 20067519, 20067520, 20067478, 20069597, 20069598, 20069601, 20072177, 20072184, 20072181, 20072182, 20072183, 20072189, 20075102, 20075104, 20077212, 20075105, 20077328, 20077391, 20077403, 20077407, 20079296, 20079297, 20079312, 20079313, 20079260, 20079261, 20079299, 20079300, 20079301, 20079315, 20084389, 20084390, 20082130, 20082175, 20082176, 20082177, 20086318, 20086319, 20082179, 20086271, 20086272, 20088628, 20088600, 20089012, 20089015, 20090190, 20090206, 20090191; c) 12251, Lot Numbers: 20054925, 20054926, 20056744, 20056745, 20057662, 20057664, 20057663, 20057665, 20058694, 20058695, 20058696, 20058697, 20061147, 20061148, 20061149, 20061951, 20061952, 20061953, 20062605, 20062608, 20062609, 20063691, 20063692, 20063693, 20064348, 20064349, 20064350, 20065664, 20065665, 20065666, 20067479, 20067501, 20067502, 20067500, 20067503, 20067504, 20069599, 20069602, 20069603, 20069600, 20069604, 20069605, 20072178, 20072188, 20072190, 20072179, 20072191, 20072180, 20072187, 20075101, 20075097, 20075098, 20075099, 20075100, 20075085, 20075086, 20075087, 20075088, 20076648, 20075089, 20075090, 20075094, 20077330, 20075095, 20077384, 20077383, 20077385, 20077375, 20077376, 20077397, 20077377, 20077378, 20077398, 20077379, 20077380, 20077381, 20077382, 20079226, 20079227, 20079228, 20079229, 20079243, 20079250, 20079252, 20079253, 20079255, 20079256, 20079235, 20079236, 20079237, 20079239, 20079240, 20079241, 20079242, 20082076, 20082077, 20082078, 20082079, 20082080, 20082082, 20082083, 20082084, 20082086, 20082087, 20082090, 20082091, 20082092, 20082103, 20082093, 20082094, 20082095, 20082073, 20082074, 20082075, 20082098, 20082070, 20082071, 20082072, 20086306, 20086309, 20086310, 20086305, 20086307, 20086308, 20086275, 20086276, 20086277, 20086278, 20086279, 20086300, 20086301, 20086302, 20086303, 20086304, 20088253, 20088256, 20088254, 20088257, 20088258, 20088259, 20088260, 20088261, 20088255, 20088262, 20088263, 20088264, 20088265, 20088266, 20088619, 20088620, 20088621, 20088622, 20088623, 20089019, 20089080, 20089081, 20089082

Quantity Affected: 5,475 cases

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-02-03

Company

Avanos Medical, Inc.

Alpharetta, GA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Avanos Medical, Inc. has 55 FDA actions in our database, including 51 recalls and 4 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Avanos Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Avanos Medical, Inc. have FDA actions?

Avanos Medical, Inc. has 55 FDA actions in our database, including 51 recalls and 4 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1406-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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