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DocumentClosedgazette notice

Homechoice Automated Pd Set With Cassette And 4 Prong Luers

South African Health Products Regulatory AuthorityRef: https://www.sahpra.org.za/document/homechoice-automated-pd-set-with-cassette-and-4-prong-luers/

Official source

Source domain: sahpra.org.za

Collected on 28 July 2026

Always confirm details on the official source before acting.

Our copy (archived 28 July 2026)Official source

What this means

This document is a SAHPRA (South African Health Products Regulatory Authority) product recall notice for a medical device: “HomeChoice Automated PD set with cassette and 4-prong luers.” Adcock Ingram Critical Care, as distributor, recalls specific lots due to an issue causing increased alarms on the HomeChoice cycler (“Check Lines & Bags” and “Reload the Set 156”), which may delay or interrupt therapy and could lead to touch contamination if aseptic technique is not followed during repeated set changes. Health professionals and distributors are instructed to quarantine and isolate affected batches and contact SAHPRA for upliftment and credit arrangements. The notice is updated on 20/07/2026 and is provided as a PDF (Version 1).

Facts

Reference

https://www.sahpra.org.za/document/homechoice-automated-pd-set-with-cassette-and-4-prong-luers/

Key Takeaways

  • Product: HomeChoice Automated PD set with cassette and 4-prong luers
  • Distributor/issuing party: Adcock Ingram Critical Care (AICC)
  • Manufacturer: Vantive
  • Reason: increased alarms during use of HomeChoice cycler
  • Most frequent alarms: “Check Lines & Bags” and “Reload the Set 156”
  • Risk: delay or interruption of therapy
  • Additional risk: potential touch contamination of sterile fluid path due to repeated set changes
  • Affected lots/batches: 25L02T005, 25L06T017, 26A02T005
  • Expiry dates: 25L02T005 (NOV 2030), 25L06T017 (NOV 2030), 26A02T005 (DEC 2030)
  • Pack size: 1’s
  • Recall classification: Class III Type C
  • Recall date: 20 July 2026
  • Advice: quarantine and isolate impacted batches; arrange upliftment and credit
  • SAHPRA contact email: enquiries@sahpra.org.za
  • Document update date: 20/07/2026
  • File type: pdf; Version: 1
  • SAHPRA (South African Health Products Regulatory Authority)
  • Adcock Ingram Critical Care (AICC)
  • Vantive
  • Ntokozo Msiza

Dates

Closing Date

20 July 2026