Device recall

Z-1084-2017: Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric…

FDA device recall · Class II · Atrium Medical Corporation

Key facts

Recall number (Z-number) Z-1084-2017
Recall event 75599
Product Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, in. tubing, Sims and Pedi connector in bag on back of drain 3612-400 Oasis Infant/Pediatric drain with no in-line connector, in. tubing, Sims and Pedi connector in bag on back of drain…
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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