Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17127 |
| Brand Name: | AMS AdVance XP Male Sling System - Needle passers |
| Model: | 720163-01 |
| Affected: | all lots |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | American Medical Systems Inc |
| Issue: | As a result of routine periodic product shelf life testing, manufacturer has identified that the sterile barrier of some samples of packaging of the Needle Passer components supplied with the AdVance® XP Male Sling System, may have potentially been breached and therefore do not consistently meet the three (3) year shelf life stated on the product label. Further testing confirms that the packaging of the Needle Passers continues to meet the requirements for the one (1) year shelf life. During implant procedures of the AdVance® XP Male Sling System, the two Needle Passers (left and right sides), are used by the Surgeon to assist transobturator passage while the placing and positioning the Sling. These tools are disposable and indicated for one-time-use only. There is a potential for an increased risk of patient infection due to breach in the sterile barrier (packaging) of the Needle Passer components. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 6/8/2014 |
