FDA recall Z-1607-2022

Mckesson Medical-Surgical Inc. Corporate Office · Class II · device

Product

GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000

Reason for recall

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Distribution

US Nationwide

Key facts

Status: Ongoing
Initiation date: 2022-05-25
Report date: 2022-08-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1607-2022