Device recall

Z-1081-2017: Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean…

FDA device recall · Class II · Atrium Medical Corporation

Key facts

Recall number (Z-number) Z-1081-2017
Recall event 75599
Product 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…
Product code PAD
Recalling firm Atrium Medical Corporation
Recall class Class II
Status Terminated
Termination date Sep 29, 2020
FEI number 3011175548

At a glance

  • None Linked 510(k)s
  • 10–99 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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