Medical Devices Archives - Page 2 of 13

25 Aug CARDIOROOT Woven grafts

Posted at 14:37h in

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...

24 Aug INFrame™ Implant 2.0mm x 28mm and INFrame™ Implant 2.0mm x 34mm

Posted at 13:50h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Medhold Medical (Pty) Ltd Block@Nature Office Park Block C3 472 Botterklapper Street Die Wilgers Pretoria, Gauteng 0041 N/A 22311-25 22311-32 N/A Set 17 August 2023 Class III Type C 21 August 2026 Brief description of the problem (reason for recall) Acumed has initiated a Voluntary...

19 Aug Percutaneous Insertion Kits 100 and 150 (PIK)

Posted at 08:48h in

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)...

13 Aug ZS70658 – VAC TUBE CLOT ACTIV+GEL SEP 5mL (2 4mL)

Posted at 13:59h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Gen Analytica 54 Maxwell Drive North Office Park Block B Suite 34 Woodmead N/A A10015 A10016 N/A 1 set 22 April 2026 Class II Type B 12 August 2026 Brief description of the problem (reason for recall) This recall is initiated due to customer complaints received reporting potassium...

12 Aug Smart Bag Flexpack Acid Concentrates

Posted at 13:37h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Fresenius Medical Care – South Africa 9 Galaxy Road Linbro Park Sandton Johannesburg. N/A See Recall letter See Recall letter 1’s 2025/10/20 Class I Type B 07 August 2026 Brief description of the problem (reason for recall) The recall is being initiated as the distributor for certain...

12 Aug General Regulations Made in Terms of the Medicines and Related Substances Act 101 of 1965: Amendment to Regulation 6: Notice of Correction

Posted at 11:43h in

The South African Health Products Regulatory Authority (SAHPRA) wishes to inform all pharmaceutical industry stakeholders that an amendment to Regulation 6 was published in Government Gazette No. 55152, Notice No. 7780, on 7 August 2026 for implementation. The published amendment contained two aspects: first, the...

23 Jul Contact Details for Guideline No. SAHPGL-MD-03 Medical Device vigilance: Adverse Events Reporting for Licence Holders

Posted at 11:37h in

This document provides contact details for reporting adverse events in accordance with the latest version of Guideline No. SAHPGL-MD-03 accessible on SAHPRA Website, Field Safety Corrective Actions. It also includes contact information for medical devices recalls, including In vitro diagnostics (IVDs)....

23 Jul Homechoice Automated PD set with cassette and 4-Prong luers

Posted at 11:31h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Adcock Ingram Critical Care 1 Sabax Road Aeroton Johannesburg 2013 South Africa N/A 25L02T005 25L06T017 26A02T005 25L02T005 (NOV 2030) 25L06T017 (NOV 2030) 26A02T005 (DEC 2030) 1’s 25L02T005(21 APR 2026) 25L06T017 (09 APR 2026) 26A02T005 (22 APR 2026) Class III Type C 20 July 2026 Brief description of the problem (reason for recall) Adcock Ingram...

25 Jun Application to Import Section 21 Ruo Medical Devices Including IVDs

Posted at 13:50h in

The application form for import of Research Use Only (RUO) and Investigational Use Only (IUO) medical devices, including in vitro diagnostic (IVD) medical devices....

25 Jun Communication on Research Use Only (RUO) and Investigational Use Only (IUO) Medical Devices including In Vitro Diagnostic Devices (IVDs)

Posted at 13:46h in

This document is intended to provide communication to stakeholders on the regulatory requirements and classification of Research Use Only (RUO) and Investigational Use Only (IUO) medical devices, including in vitro diagnostics (IVD)....

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