19 Aug Percutaneous Insertion Kits 100 and 150 (PIK)
| Company name & Address: | Registration number | Batch number(s) | Expiry date | Pack size | First Distribution date | Re-call Classification | Recall date |
| Surgical Innovation Pty Ltd
Stand 208C Hoogland Ext 44 Cnr Apsom Avenue and Malibongwe Drive Boundary Park Northriding Randburg 2169 |
N/A |
04037691519883
04037691730660 04037691519876 04037691730677 04037691746500 04037691746517
|
N/A |
1 set |
April 2021 |
Class II Type B |
12 August 2026 |
Brief description of the problem (reason for recall)
Maquet Cardiopulmonary GmbH the Original Equipment Manufacturer (OEM) has identified that there have been failures in sterile barrier integrity verification testing. OEM is recalling the affected lot numbers due to a potentially compromised sterile barrier.
Advice for health professionals and distributors:
Further use or distribution of the above lot numbers must be discontinued immediately. Urgently check your internal inventory and quarantine the affected products. Surgical Innovations will arrange for upliftment and/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) 82 870 8234 or email mariettek@surgicalinnovations.co.za.
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.