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U.S. Department of Health and Human Services

Class 2 Device Recall Catheters, suction, tracheobronchial

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 Class 2 Device Recall Catheters, suction, tracheobronchialsee related information
Date Initiated by FirmNovember 22, 2021
Create DateMarch 31, 2022
Recall Status1 Terminated 3 on January 31, 2023
Recall NumberZ-0845-2022
Recall Event ID 89132
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
ProductBALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use
Code Information Finished Product Code: 102008602; Alternate Code: 24013-5; Lot No.: 30143745.
Recalling Firm/
Manufacturer		 Avanos Medical, Inc.
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information ContactLisa Clark
470-448-5444
Manufacturer Reason
for Recall		Product was distributed with incorrect expiration date.
FDA Determined
Cause 2		Labeling Change Control
ActionThe firm sent out a Urgent Advisory Notice dated 11/22/2021 via email to consignees notifying them of recall and identifying affected lots. Consignees were informed to check their unused inventory for affected product, and to subsequently quarantine and destroy any recalled product. Additionally, consignees were provided with a Recall Acknowledgement Form that was to be completed within five business days of receipt and returned to fieldactioncare@avanos.com. Consignees that have used recalled product and have no additional units in stock are instructed to complete the Recall Acknowledgement Form indicating that they have no inventory of impacted products.
Quantity in Commerce20 devices (1 case)
DistributionWorldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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