| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00929-1 |
| Product Name/Description |
Suction Adapter Type A (Gauge)
Reference Number: X05101
Lot Number: Z141203
ARTG Number: 194212 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has become aware that the affected connector may have a defective Limit Pin on the On-Off Lever, which would cause the pin to stick to the groove on the back of the On-Off lever. This may result in the lever to break, resulting being unable to turn on or off the valve.
This recall was undertaken prior to approval by the TGA. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Xcel Medical Solutions is requesting users to quaratine affected stock and return to Xcel Medical Solutions for replacement or full refund.
This action has been closed out on 09/01/2019 |
| Contact Information |
02 8004 6856 - Xcel Medical Solutions |