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U.S. Department of Health and Human Services

Class 2 Device Recall Ballard Oral Care Swab

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  Class 2 Device Recall Ballard Oral Care Swab see related information
Date Initiated by Firm February 03, 2023
Date Posted April 19, 2023
Recall Status1 Open3, Classified
Recall Number Z-1406-2023
Recall Event ID 91741
Product Classification Applicator, absorbent tipped, non-sterile - Product Code KXF
Product Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
Code Information 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
Recalling Firm/
Manufacturer		 Avanos Medical, Inc.
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact Lisa Clark
470-448-5444
Manufacturer Reason
for Recall		 Incorrect expiration date.
FDA Determined
Cause 2		 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 in Commerce 5,475 cases
Distribution Worldwide distribution - US Nationwide and the countries of Canada, Germany, Netherlands, France, Switzerland, Great Britain, Israel, and India.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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