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FDANovember 29, 2016device

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.  T...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Outer Packaging is not sterile

What to do

FDA enforcement status: Terminated

Brands named

atrium medicalatrium

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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.  T... — Recall Details · AllClear