| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00422-1 |
| Product Name/Description |
PenAdapt
(an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed)
Item number: 0702045027
Multiple lot numbers
ARTG Number: 171568 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
During packaging verification testing, a breach in the sterile barrier was observed in some of the units tested. Additional testing identified microscopic aluminium metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches in some of the units tested. It was determined that these particles were introduced during the manufacturing process and were sterilised within the Tyvek pouch with the product. The potential hazards of this Product Issue include patient exposure to infectious material, potentially leading to patient infection, and patient exposure to sterile foreign material potentially leading to foreign body inflammation. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to check any PenAdapt items in their possession and quarantine any affected units immediately. A Stryker Representative will contact customers to coordinate an inspection of the affected items in quarantine. Any affected items will be removed by the Stryker Representative and a credit will be issued to the customer account. Stryker is also requesting the customers to review the patient records for issues that may have been associated with the use of the affected device, such as infection and/or inflammation. |
| Contact Information |
1800 803 601 - Stryker |