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TGA Action ID	RC-2025-RN-00860-1
Type of Product	Medical Device
Product Name/Description	IV Gravity Burette Set Description: 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap Item Number: 011-C7014 Lot Numbers: 5861799, 13830061, 13850321, 13854135, 13992404, 14029638, 14065820, 14110075, 14129823, 14179569, 14211300
ARTG Number	269616
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	ICU Medical has identified a lot-specific problem regarding IV Gravity Burette Set where the tubing connected to burette component of the IV Set may separate due to insufficient solvent between the burette and tubing. If the device separates a leak may occur. During setup, this may result in a delay in therapy. During use, this may result in an interruption of therapy, air may be infused into the body, and the patient may be exposed to the substance being administered.
Instructions for Customers/Users	Customers are to: 1. Check all inventory locations and quarantine all affected products. 2. Destroy all affected products following institution’s process for destruction. 3. ICU Medical will provide replacement stock upon receiving the Customer Response Form sent to affected customers.
Action Commencement Date	13/10/2025
Responsible Entity	ICU Medical Australia Pty Ltd
Contact Information	1300 428 652 - ICU Medical Customer Service