Type of Product |
Medical Device |
TGA Recall Reference |
RC-2012-RN-00785-3 |
Product Name/Description |
Captura Disposable Biopsy Forceps (endotherapy forceps, flexible, single use)
Reorder Number: DBF-2.4SN-230-S (16 boxes of 10)
Lot Number: W3074075
ARTG Number: 176865 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
3/08/2012 |
Responsible Entity |
|
Reason/Issue |
The forceps inside the packaging may be the incorrect configuration. Specifically, the outer packaging indicates the product is DBF-2.4SN-230-S (has non-spiked forceps head), but the forceps inside are actually DBF-2.4SL-230SP-S (has spiked large forceps head). |
Recall Action |
Recall |
Recall Action Instructions |
Quarantine and return affected devices to Cook Medical. |
Contact Information |
1800 457 4500 - Customer Relations Department |