| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00728-1 |
| Product Name/Description |
BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder 21G & 22G.
21G
Catalogue Number : 368835
Lot/Batch Numbers
4302105 4266252
4302106 4276343
4346490 4344023
4252010 5041109
4259413 5072433
22G
Catalogue Number :368836
Lot/Batch Numbers
4268488 4346068
4302103 5027368
4346062
ARTG Number: 128397 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
BD has become aware that some lots of the BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder (Catalogue Numbers 368835 and 368836) have the potential for the integrated holder to become detached from the needle. This detachment can lead to possible sample collection failure, and in exceptional circumstances, have the potential to cause a needle stick injury.
The manufacturer has estimated that the frequency of this failure mode is 0.198%. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
BD is providing instructions to allow the continued use the Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder:
- Prior to use, ensure that the pink Eclipse Shield is positioned over the green or black needle cover.
Grasp the needle cover and pink Eclipse Shield together and the holder in the other hand and pressing firmly down on the pink Eclipse Shield pull in a straight direction. Do not bend the device whilst pulling.
- If the holder becomes detached, dispose of the device in an appropriate sharps collector. This action has been closed-out on 17/08/2016. |
| Contact Information |
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