FDA recall Z-0846-2022

Avanos Medical, Inc. · Class II · device

Product

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

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.

Key facts

Status
Terminated
Initiation date
2021-11-22
Report date
2022-04-06
Termination date
2023-01-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Alpharetta, GA, United States

Primary source

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