Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27839 |
| Brand Name: | Contura - Bulkamid |
| Model: | |
| Affected: | Batch Numbers: 18F0304AA, 18F0401AA, 18F0402AA, 18F0402AA, 18F0702AA, 19F0102AA, 19F0102AA, 19F0103AA, 19F0301AA, 19F0402AA, 19F0602AA, 19F0702AA, 19F0704AA, 19F0704AA,19F1101AA, 19F1103AA, 19F1103AA, 19F1105AA |
| Software version: | |
| Recalling Organisation: | Downs Distributors Ltd 9 Airborne Road North Harbour AUCKLAND |
| Contact Information: | 0800 800 234 |
| Manufacturer: | Contura International A/S |
| Issue: | The manufacturer is recalling unused product due to a potential lack of sterility assurance of the Bulkamid Needles included in the product. The manufacturer has been informed of suspected falsification of records and validation documentation by a third-party sterilization facility related to the sterilization process of Bulkamid Needles |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/6/2021 |
