FDA-Device2022-04-06Class II
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Hazard
Product was distributed with incorrect expiration date.
Sold states
Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.
Affected count
2,520 devices (126 cases)
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0847-2022More Avanos Medical, Inc. recalls
- FDA-Device2026-06-17Avanos Medical MIC Safety PEG Kit 24 Fr recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos CORFLO Safety PEG Kit recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos CORFLO Safety PEG Kit with ENFit Connector recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos MIC Safety PEG Kit recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos Medical MIC Safety PEG Kit recalled for defective lidocaine injection
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