Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:20013
Brand Name:American Surgical Sponges/15252/sponges
Model:AS-30-00, AS-30-02, AS-30-03, AS-30-04, AS-30-07 and AS-63-01
Affected:
Software version:
Recalling Organisation:InterMed Medical Ltd
71 Apollo Drive
Albany
AUCKLAND 1311
Contact Information:0800 333 444
Manufacturer:American Surgical Sponges
Issue:A failure in the sterile peel pouch has been discovered during a quality control inspection. This failure may result in a small tear in the pouch of the device leading to a potential compromised sterile barrier. A leak in the sterile barrier may allow contamination of the device increasing the risk of infection. After the failure was identified, a comprehensive investigation has shown an occurrence rate of less than 0.01% for the affected lots.
The customer was credited & the supplier agreed to have the product destroyed off site.
Recall action type:Recall
Recall action:Product to be destroyed
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:12/4/2016
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