25 Aug CARDIOROOT Woven grafts
| Company name & Address: | Registration number | Batch number(s) | Expiry date | Pack size | First Distribution date | Re-call Classification | Recall date |
| Marcus Medical (Pty) Ltd 63 Old Pretoria Main Road Midrand
Johannesburg South Africa. |
N/A |
24E09 24G04 24F06 24E23 24E16 24G04 24F20 25D03
|
N/A | Set
|
23 September 2024
|
Class I Type C | 24 August 2026 |
Brief description of the problem (reason for recall)
Marcus Medical (Pty) Ltd has received URGENT FIELD SAFETY ACTION (REF: RC045 – 1574541 Revision 3) from Getinge that manufacturer Intervascular SAS, a subsidiary of Getinge, is voluntarily recalling CARDIOROOT Woven grafts because internal testing conducted on samples from the affected product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
Advice for health professionals and distributors:
Advised checking if you have stock of the lot above and stop use of affected medical device and return stock to Marcus Medical (Pty) Ltd. Return Completed Acknowledgement of Notification and Confirmation of Stock on hand and for upliftment (Page 6 of 11) to Marcus Medical (Pty) Ltd regulatory@marcusmed.co.za or give to the Sales Representative.
Marcus Medical (Pty) Ltd will arrange for upliftment. A Credit or Replacement will be determined on affected stock that is returned once completed acknowledgement is received.
We appreciate your immediate attention and cooperation
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.