FDA-Device2022-04-06Class II

BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; 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
20 devices (1 case)
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0845-2022

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