FDA Medical Device Recalls (openFDA)
Avanos Medical, Inc.: BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
- Recall number
- Z-0847-2022
- Recalling firm
- Avanos Medical, Inc.
- Product
- BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
- Status
- Terminated
- Initiated
- 2021-11-22
- Posted
- not on file
- Terminated
- 2023-01-31
- 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 Form indicating that they have no inventory of impacted products.
- Quantity
- 2,520 devices (126 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.
- Lot, serial or model codes
- Finished Product Code: 102007202; Alternate Code: 240168-5; Lot No.: 30135997, 30137462, 30138710, 30140310, and 30141359.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSY
- Firm FEI
- 3011270181
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28