BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
This recall has been terminated (originally issued November 22, 2021).
- Company
- Avanos Medical, Inc.
- Recall Initiated
- November 22, 2021
- Terminated
- January 31, 2023
- Recall Number
- Z-0846-2022
- Quantity
- 6,280 devices (314 cases)
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Product was distributed with incorrect expiration date.
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.
Lot / Code Info
Finished Product Code: 102005202; Alternate Code: 24014-5; Lot No.: 20065842, 30135996, 30135999, 30137463, 30140309, 30138711, and 30141360.
Root Cause
Labeling Change Control
Action Taken
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.