FDA recall Z-0235-2023

Atrium Medical Corporation · Class II · device

Product

Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000

Reason for recall

Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.

Distribution

US Nationwide distribution in the state of VA.

Key facts

Status
Ongoing
Initiation date
2022-10-18
Report date
2022-11-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Merrimack, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0235-2023