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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00821-1
Product Name/Description	Check-Flo Performer Introducer Set Reference part number: RCF-5.0-35-45-J Order number : G27242 Lot number: 15506769 UDI: (01)00827002272422(17) 260626(10)15506769 Expiry date: 23-Jun-2026 ARTG 137859 (William A Cook Australia Pty Ltd - Standard Introducer Sets - Catheter introducer)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	13/09/2024
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	Devices from lot 15506769 may have white caps that connect the shaft to the hub of the products that may disconnect. There is a possibility that this may result in an increased procedural time, harms associated with device fragmentation/separation, and/or haemorrhaging/blood loss.
Recall Action	Recall
Recall Action Instructions	Customers are to examine inventory immediately for affected product, quarantine and cease use. Once returned to Cook Medical, a product credit will be issued.
Contact Information	1800 777 222 - Cook Medical Customer Relations