ClearanceBrief
Recall Z-1079-2017 ยท PAD Chest Drainage Kit

Atrium Medical Corporation

Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Ocean single drain, in-line connector and suction control stopcock, Pedi connector in bag on back of the drain 2002-050 Ocean single drain with in-line connector and suction control stopcock, Pre-connected 2550 ATS Bag 2002-100 Ocean single drain with in-line connec

DateNov 29, 2016
StatusTerminated
ReasonOuter Packaging is not sterile
Root causePackage design/selection
ActionAtrium Medical issued recall letter on 11/29/16 via two-day express mail delivery advising users: of the problem, updated instructions for use; the new Warning Label applied to the packaging; and requesting to post the warning label near all Atrium chest drain product inventory. A Field Notification Reply Form acknowledging receipt of the Field Notification was requested to be completed and returned. Questions contact Atrium/Maquet/Getinge chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).
Quantity964,463 cases (US) 521,975 cases (OUS) in total
DistributionWorldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zea
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.