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OFFICIAL-SOURCE RECALL · AUSTRALIA

Various Blood Transfusion Sets, Basic Intravenous Administration Recall: Classification Class III Reason for

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CountryAustraliaPublishedAugust 17, 2026Last updatedAugust 17, 2026Official source last checkedAugust 26, 2026 at 7:44 PM UTC

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Brand
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Product
Various Blood Transfusion Sets, Basic Intravenous Administration Sets, Medication Transfer Sets, and Electric Infusion Pump Administration Sets
Manufacturer
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Lot number
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Date code
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The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.

Why this product was recalled

Classification Class III Reason for the Action ICU Medical received reports of discolouration observed in the drip chambers of certain IV tubing sets. Instructions for Customers/Users ICU Medical's investigation into the problem confirmed that the observed discolouration is characteristic of the drip chamber material, does not enter the fluid path, and does not affect device safety, performance, or intended use. The completed investigation supports continued use of products in accordance with their intended use and standard clinical practices. Healthcare providers should therefore continue using products in accordance with the Instructions for Use and established clinical procedures per facility protocol. No product returns are necessary. Action Commencement Date 17/08/2026 Responsible Entity ICU Medical Australia Pty Ltd

Hazard

Classification Class III Reason for the Action ICU Medical received reports of discolouration observed in the drip chambers of certain IV tubing sets. Instructions for Customers/Users ICU Medical's investigation into the problem confirmed that the observed discolouration is characteristic of the drip chamber material, does not enter the fluid path, and does not affect device safety, performance, or intended use. The completed investigation supports continued use of products in accordance with their intended use and standard clinical practices. Healthcare providers should therefore continue using products in accordance with the Instructions for Use and established clinical procedures per facility protocol. No product returns are necessary. Action Commencement Date 17/08/2026 Responsible Entity ICU Medical Australia Pty Ltd

Official recall notice

Various Blood Transfusion Sets, Basic Intravenous Administration Sets, Medication Transfer Sets, and Electric Infusion Pump Administration Sets

Agency: Therapeutic Goods Administration

Official publication date: August 17, 2026

Read the official AU_TGA_DRAC recall notice →

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