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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-01160-1
Product Name/Description	Catheter Kit Model reference: 061PC04001 and 061PC04002 Lot numbers: 21B166, 21G051, 21G052, 21G053, 21H029, 21J123, 22C013, 22D092 ARTG 99244 (ITL Australia Pty Ltd - Surgical procedure kit, single use)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	22/08/2022
Responsible Entity	ITL Australia Pty Ltd
Reason/Issue	ITL is notifying that sterility maybe compromised for part of the procedure pack. Due to the error, patients have a higher theoretical risk for blood stream infection. No adverse events have been reported to date due to the error.
Recall Action	Recall
Recall Action Instructions	ITL are advising customers to quarantine the impacted lots to prevent further use and return the affected lots. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	1300 188 493 - Customer care - ITL