01 Jun Mx-ava 500 Mpat Syringe Set Multi Patient
| Company name & Address: | registration number | Batch number(s) | Expiry date | Pack size | First Distribution date | Re-call Classification | Recall date |
| Cardio Tech (Pty) Ltd t/a Cardaxes
Stand 208 C, Hoogland Ext 44, Corner Epsom Avenue and Malibongwe Drive, Boundary Park, Northriding, Randburg, 2169 |
N/A |
251702 |
21 April 2027 |
1 set |
22 April 2026 |
Class II Type C |
18 May 2026 |
Brief description of the problem (reason for recall)
Bayer identified that a recent change to a component of the MPAT stopcock resulted in a failure of the product to consistently and reliably engage with the Contrast Flow Control Valve (CFCV) snap interface on the Avanta Injection System.
Advice for health professionals and distributors:
Further use or distribution of the above lot numbers must be discontinued immediately. Immediately check your internal inventory and quarantine the affected products. Cardaxes will arrange for upliftment and replacement of stock or credits as applicable. If any of the recalled stock could have been transferred from your institution to another, please let that institution know or alternatively inform our company so that we can contact the institution supplied from your institution.
Should you have any queries regarding this matter, please contact us on +27 (0) 72 419 7445 or email davek@cardaxes.com.
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.