Atrium Medical Corporation: Medical Device Recall in 2017 - (Recall #: Z-1081-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction control stopcock, ¿ in. Tubing, Sims and Pedi connector in bag on back of drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.

Product Classification:

Class II

Date Initiated: November 29, 2016

Date Posted: February 1, 2017

Recall Number: Z-1081-2017

Event ID: 75599

Reason for Recall:

Outer Packaging is not sterile

Status: Terminated

Product Quantity: 964,463 cases (US) 521,975 cases (OUS) in total

Code Information:

All Lot Numbers With Expiration Date Prior To October 2019

Distribution Pattern:

Worldwide 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 Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,

Voluntary or Mandated:

Voluntary: Firm initiated