Device recall

Z-1297-2022: Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation…

FDA device recall · Class II · Atrium Medical Corporation

Key facts

Recall number (Z-number) Z-1297-2022
Recall event 90295
Product Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028
Product code GBZ
Recalling firm Atrium Medical Corporation
Recall class Class II
Status Open, Classified
FEI number 3011175548

At a glance

  • None Linked 510(k)s
  • 1–9 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

Browse all FDA device recalls (products)