Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:28276
Brand Name:Atrium Pneumostat
Model:Part number - 16100
Affected:
Software version:
Recalling Organisation:Getinge Australia Pty Ltd (NZ)
Unit D, Ground Floor, Building A, Millenium Centre
600 Great South Rd
Ellerslie
Auckland 1051
Contact Information:09 272 9039
Manufacturer:Atrium Medical Corporation
Issue:The manufacturer has received a complaint involving an event in which a preterm infant required prolonged resuscitation, was intubated and ventilated with difficulty. A resulting left tension pneumothorax subsequently developed and was treated with needle decompression followed by placement of an intercostal catheter (chest tube) which was connected to an Atrium Pneumostat Chest Drain Valve (a 'gravity only' device; no active suction function).
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:2/9/2021
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /