01 Jun Residual Barrier Technology (RBT) Protectus Med 1lt
| Company name & Address: | registration number | Batch number(s) | Expiry date | Pack size | First release date | Re-call Classification | Recall date |
| Axim
AXIM House 63 Old Pretoria Road Halfway House Ext.2 Midrand South Africa |
N/A |
03/1M260411/01 |
February 2028 |
1 litre |
10 February 2026 |
Class II Type C |
19 May 2026 |
Brief description of the problem (reason for recall)
This recall is initiated due to testing of the product in the lab indicating growth on Total Plate Count (TPC), the effectiveness of the product cannot be confirmed.
Advice for health professionals and distributors:
We request that you refrain from selling any of the affected batch(s) of 1lt Protectus Med RTU and return them to your supplying warehouse or distributor with immediate effect. We will collect all your stock, which will be replaced within 10 days. For further product information, please call Janice Meissner on 082 887 1753.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.