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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00922-1
Product Name/Description BD Epilor Plastic BD Luer-Lok Loss of Resistance (LOR) Syringe (7mL) (Used in conjunction with an epidural needle for identifying epidural space)

Reference Number: 405291

Lot Numbers: 0039440, 0154661, 0174905, 0252565, 1012200, 1124755, 1213029, 1312116, 1320204, 2286395, 2303141, 2334338, 2334339, 8277525, 8357843, 9093622 and 9149990

ARTG Number: 120174
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/09/2013
Responsible Entity Becton Dickinson Pty Ltd
Reason/Issue BD has received complaints relating to difficulty in moving the plunger rod or the plunger rod sticking. This has the potential to prevent the anaesthetist from correctly detecting the loss of resistance upon entering the epidural space.
Recall Action Recall for Product Correction
Recall Action Instructions Prior to using each syringe, it is recommended that anaesthetists ensure that there is no difficulty in moving the plunger rod and that the plunger rod does not stick. Any LOR Syringe that shows inappropriate resistance should be discarded; the procedure can then be continued by using another LOR Syringe that does not show resistance.
Contact Information 1800 6256 100 - Becton Dickinson Regulatory Affairs