FDA recall Z-0845-2022

Product

BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; 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-0845-2022