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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