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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-01400-1
Product Name/Description	BD Connecta Stopcock with extension tube - 100 cm Catalog number: 394961 Batch number: 2060614 ARTG 126507 (Becton Dickinson Pty Ltd - Infusion stopcock)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/11/2022
Responsible Entity	Becton Dickinson Pty Ltd
Reason/Issue	Becton Dickinson has confirmed through internal investigation that a certain lot may present a hole or rupture in the unit blister packaging. As a result of this potential defect the sterility of the product may be compromised. No adverse events have been reported relating to this issue in Australia.
Recall Action	Recall
Recall Action Instructions	Customers are advised to review their inventory and destroy any impacted stock. Customers should record the amount destroyed on the acknowledgment form (supplied to impacted facilities by the sponsor) and return to BD for a credit. For devices in situ, they should continue to be maintained and replaced in accordance with the hospital/institution’s normal practices, unless there is a clinical suspicion of an infection related or unrelated to these devices. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	02 8875 7000 - Becton Dickinson Pty Ltd