FDA-Device2022-04-06Class II

BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use

Avanos Medical, Inc.
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
6,280 devices (314 cases)
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0846-2022

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