28 Apr Kiwi Complete Vacuum Delivery System
| Company name & Address: | registration number | Batch number(s) | Expiry date | Pack size | First release date | Re-call Classification | Recall date |
| Pharmaco Distribution 91 Protea Road Chislehurston Sandton
2196 |
N/A |
251485 |
23 October 2027 |
1 sterile unit per pack |
22 December 2025 |
Class I Type B |
17.April.2026 |
This recall is being conducted due to a manufacturing defect that may result in breakage of the handle at the Traction Force Indicator (TFI) handle joint when angular force is applied.
This defect may compromise the integrity of the bond between the TFI and the handle during use under certain techniques.
Risk to Health
Breakage of the device may result in sudden loss of vacuum, which could lead to a delay in the procedure while an alternative delivery method is implemented, including possible conversion to caesarean section.
Delays in delivery may increase the risk of harm, particularly where vacuum-assisted delivery is indicated due to fetal distress.
In procedures performed during caesarean section, there is also a potential risk that device fragments may enter the surgical field.
Reporting adverse events
Healthcare professionals and members of the public are encouraged to report any adverse events associated with the use of this device via the Med Safety App, or by contacting the Pharmaco Distribution Pharmacovigilance Department at Tel: 011 784 0077 or za.complaints@pharmaco.co.za. Reporting contributes to the ongoing safety monitoring of medical devices.