| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00295-1 |
| Product Name/Description |
Endo-Scrub2 Sheaths and Tubing Set
Sheath Models #’s (w/ tubing): 1912000, 1912004, 1912008, 1912032, 1912033, 1912038, 1912040, 1912050
Tubing Model #’s: 1912030
Multiple lot numbers
ARTG numbers: 125734 and126694 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
18/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
The luer connector on the end of the tubing that attaches to the sheath may break off, either prior to or during use. Once the connector breaks, the flow of saline to the sheath either ceases or is reduced and leakage occurs at the fracture site. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic is requesting end users to inspect the luer connection for breakage at the point of use. Any broken tubing sets are to be discarded. New tubing sets will be provided to replace broken devices. |
| Contact Information |
02 9857 9234 - Medtronic Australasia Pty Ltd |