| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01163-1 |
| Product Name/Description |
Plastic Cannula – 11 gauge
Catalogue Number: 9391-0200
Lot Numbers: 1470303001, 1470304601, 1470306301, 1470311301, 1470314801, 1570314802, 1570317701, 1570317702, 1570317704, 1570322001
ARTG Number: 189737 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Becton Dickinson (BD) has identified punctures in the blister packaging detected during the packaging process for specific lots of Plastic Cannula – 11 gauge.
A breach in the sterile barrier has the potential to render the device non-sterile. It is possible end users may not detect the pin holes, thus utilising impacted product clinically. This could result in harm to patients especially when immunocompromised.
In association with this recall, BD has decided to discontinue Catalogue Number: 9391-0200.
To date, BD is not aware of any report of injury attributed to this defect in Australia. |
| Recall Action |
Recall |
| Recall Action Instructions |
1. Users are to discontinue use of and segregate the identified Lot Numbers of Catalogue Number 9391-0200 (Plastic cannula – 11 gauge).
2. Complete the supplied Customer Acknowledgement Form to confirm receipt of this notification.
3. Becton Dickinson is requesting that any impacted inventory be returned.
4. Becton Dickinson will arrange for the pick-up of your affected stock and issue a credit to your account.
This action has been closed out on the 16/10/2018. |
| Contact Information |
1800 833 372 - CareFusion Customer Service |