Recall Z-0846-2022 ยท BSY Catheters, Suction, Tracheobronchial
Avanos Medical, Inc.
BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
| Date | Nov 22, 2021 |
| Status | Terminated |
| Reason | Product was distributed with incorrect expiration date. |
| Root cause | 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 F |
| Quantity | 6,280 devices (314 cases) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.