| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00181-1 |
| Product Name/Description |
Sureclip and Sureclip Plus Haemostasis Clips (Gastrointestinal endotherapy clip applier)
Hemoclip 90 degree/5mm/12mm(max) rotatable/relocatable (x10/box)
Product Code: ROCC-D-26-230-C
Lot Number: 150625231
Expiry Date: 24/06/2018
Hemoclip 90 degree/8mm/17mm(max) rotatable/relocatable (x10/box)
Product Code: ROCC-F-26-230-C
Lot Number: 151115231
Expiry Date: 15/11/2018
ARTG Number: 261692 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
CK Surgitech has been notified of an incident concerning one of the above products. The device proved hard to fire, and upon deployment, detached a 10cm piece of wire that was removed through the scope with biopsy forceps. There is a risk of tissue puncture as a result of the issue.
As a result, CK Surgitech is recalling both the standard Sureclip and the Sureclip Plus until investigations have been undertaken. |
| Recall Action |
Recall |
| Recall Action Instructions |
CK Surgitech is advising users to inspect stock and quarantine affected units. Affected stock will be replaced or an alternative product supplied. |
| Contact Information |
07 5537 1147 - CK Surgitech |