Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00951-1
Product Name/Description Bolton Surgical - Sims Speculum D/E Insulated Large 33 x 38 mm 18.5cm

Product Code: ENG-17/1847/6

Batch/Lot Number: 117696

ARTG Number: 175488
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 21/09/2012
Responsible Entity Device Technologies Australia Pty Ltd
Reason/Issue It has been identified that there is a possible fault in the affected batches due to inadequate bonding between the coating and substrate in manufacturing, which may cause insulation to crack and lift away from the metal body.
Recall Action Recall
Recall Action Instructions Customers to identify and segregate any units from affected batch number and contact the sponsor to arrange return of recalled stock and order replacement stock.
Contact Information 0431 963 777 - Sharon Heley