Archive

27 Aug Ciplasyl Plus 4 tablets

Posted at 08:44h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Zydus Healthcare SA (Pty) Ltd Southdowns Office Park, Building A, 2nd Floor 22 Karee Street Centurion 0157 44/7.1.3/0503 MA04847A MB02129A MA04848A MA04900A MB02127A MB02128A MA04847A Exp.10/2028 MB02129A Exp.02/2029 MA04848A Exp.10/2028 MA04900A Exp.10/2028 MB02127A Exp. 02/2029 MB02128A Exp. 02/2029 30’s MA04847A - 12/02/2026 MB02129A - 06/05/2026 MA04848A - 19/01/2026 MA04900A - 12/02/2026 MB02127A - 06/05/2026 MB02128A -...

27 Aug Imager™ II Angiographic Catheter

Posted at 08:42h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Boston Scientific No. 8 Anslow Crescent Anslow Office Park Bryanston 2021. N/A As per recall letter 08 October 2026 to 09 June 2028 each 16 October 2024 Class II Type B 25 August 2026 Brief description of the problem (reason for recall) Boston Scientific is initiating...

25 Aug Communication to Industry – Participation in the Survey and Pilot Project on the Advertising of Health Products in South Africa

Posted at 17:09h in

The South African Health Products Regulatory Authority (SAHPRA) invites all stakeholders to participate in the survey regarding the advertising of medicine in South Africa. SAHPRA is mandated by the Medicine and Related Substances Act 101 of 1965 to regulate medicines, scheduled substances and medical devices....

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)...

18 Aug Frusemide 20 mg/2 ml Fresenius (Furosemide)

Posted at 08:46h in

Company name & Address: Registration number Batch number(s) Registered Expiry Date (Labelled Expiry Date) Pack size First release date Re-call Classification Recall date Fresenius Kabi South Africa (Pty) Ltd 7 Kingfisher Avenue Midpoint 162 Tonetti Street Halfway House Ext. 7, Midrand Gauteng, 1685 PO Box 4156 Halfway House Gauteng, 1685 K/18.1/207 90TEA870 90TIA300 90TKB190 90TLA480 90UCA000 90UEA840 90UIA510 90UIA530 90WEA230 30 April 2027 (30 April 2029) 31 August 2027 (31 August 2029) 30...

13 Aug Guideline for Health Product Traceability: Update on Implementation

Posted at 15:24h in

As part of implementing the Traceability Guideline on Health Products, the South African Health Products Regulatory Authority (SAHPRA)continues to engage with industry stakeholders, sector associations, and public-sector partners as the project moves from planning phase to delivery. An important part of this work is the survey...

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...