Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21424 |
| Brand Name: | Sterilisation Process Indicators - Enzymatic/ chemical |
| Model: | |
| Affected: | Roll Size 1322-24MM, Lot 2018-04RA, 2018-05RB, 2018-06RC, 2018-06RD. Roll Size 1355-18MM, Lot 2018-04RA, 2018-05RB, 2018-06RD. Roll Size 1355-24MM, Lot: 2018-04RA, 2018-05RB, 2018-06RD |
| Software version: | |
| Recalling Organisation: | 3M New Zealand Ltd 250 Archers Road Glenfield AUCKLAND 0627 |
| Contact Information: | 0800 808 182 |
| Manufacturer: | Solventum US LLC |
| Issue: | The manufacturer has confirmed that some rolls within the four (4) affected lots failed to meet the visual standard for colour development following exposure to steam sterilisation. If the product fails to meet the colour development standard it could be interpreted that the pack has not been exposed to an adequate sterilisation process. |
| Recall action type: | Recall |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/5/2017 |
