Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00909-1
Product Name/Description Herculite Ultra

Product description/part number/lot number:

Herculite Ultra Unidose Refill C4 Enamel
35166
4650240,4718337, 4665811

Herculite Ultra Unidose Refill A2 Enamel
34348
4662093, 4678965, 4662092, 4667889, 4664839, 4681753, 4678966

Herculite Ultra Unidose Refill A3.5 Enamel
34448
4863611, 4861157, 4857439, 4786373, 4791140, 4791138, 4779744, 4734549 (Syringe)

Herculite Ultra Refill Syringe A2 Enamel
34338
4711654, 4672953, 4672288, 4734007, 4720200

ARTG : 99818
Recall Action Level Retail
Recall Action Classification Class III
Recall Action Commencement Date 18/08/2014
Responsible Entity Kerr Australia Pty Ltd
Reason/Issue Kerr Corporation have received complaints that some Herculite Ultra products may be difficult to extrude or may not perform as intended. As a result, any composite extruded could exhibit signs of dryness and may not exhibit proper handling characteristics.
Recall Action Recall
Recall Action Instructions End users are advised that if they have any of the affected product in their inventory to immediately return it to Kerr Australia. This action has been closed-out on 01/03/2016.
Contact Information 1800 643 603 - Kerr Australia