| Class 2 Device Recall Catheters, suction, tracheobronchial | |
Date Initiated by Firm | November 22, 2021 |
Create Date | March 31, 2022 |
Recall Status1 |
Terminated 3 on January 31, 2023 |
Recall Number | Z-0845-2022 |
Recall Event ID |
89132 |
Product Classification |
Catheters, suction, tracheobronchial - Product Code BSY
|
Product | BALLARD* 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 Contact | Lisa Clark 470-448-5444 |
Manufacturer Reason for Recall | Product was distributed with incorrect expiration date. |
FDA Determined Cause 2 | Labeling Change Control |
Action | The 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 Commerce | 20 devices (1 case) |
Distribution | Worldwide 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 Cycle | TPLC Device Report |
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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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