01 Nov Esenta Stomahesive Paste
| Company name & Address: | registration number | Batch number(s) | Expiry date | Pack size | First distributed | Re-call Classification | Recall date |
| Adcock Ingram Critical Care
1 Sabax Road, Aeroton, Johannesburg |
N/A |
5L00431 |
01 Nov 2030 |
1 Tube (56.7G) |
27 Aug 26 |
Class II Type C |
28 October 2026 |
Brief description of the problem (reason for recall)
Adcock Ingram Critical Care (Pty) Ltd (AICC), in its capacity as the local distributor of ESENTA™ Stomahesive Paste is issuing a Medical Device Recall. The manufacturer, Convatec, has identified a quality related issue involving the potential presence of foreign matter within certain batches of ESENTA™ Stomahesive Paste. The manufacturer has identified a potential quality issue involving the presence of foreign matter within a limited number of units from the affected batch. The presence of foreign matter may impact the quality and intended performance of the device. Potential adverse effects associated with the use of the affected product may include:
- Local inflammatory response
- Skin irritation or rash
- Minor infection
- Mucosal irritation
- Allergic reaction No serious adverse events have been reported in South Africa to date.
Advice for health professionals and distributors:
If you have received any units from the affected batch, please immediately quarantine and isolate all remaining stock and discontinue any further distribution, sale, dispensing or use of the product.
Please contact the individuals listed below to arrange for the collection and credit of all affected units: Amina Mbonane (QA Release Manager): 011 494 8586 Nomazizi Semane (Senior Complaints Co-ordinator): 011 494 8744.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.