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.
FDA Recall Z-1081-2017 · Posted None
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Recalling FirmAtrium Medical Corporation
Recall StatusTerminated
Product CodePAD
Date Initiated2016-11-29
Date Terminated2020-09-29
Product Quantity964,463 cases (US) 521,975 cases (OUS) in total
Reason for Recall
Outer Packaging is not sterile
Firm Action
Atrium 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).
Root Cause
Package design/selection
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,
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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