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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01503-1
Product Name/Description	Transseptal Needle Lot Number: 8181945 Reference Part Number: TSNC-18-71.0 Global Part Number: G02364 ARTG 155227
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	13/12/2017
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	Cook Medical has become aware that certain Transseptal Needles may be the incorrect length, and is initiating a recall of lot 8181945. Potential adverse events may occur by using the nonconforming products, including being unable to perform the transseptal puncture. This could necessitate replacing the device or rescheduling the procedure. In addition, use of the nonconforming products could make the puncture less controlled, which could potentially lead to injury of the heart.
Recall Action	Recall
Recall Action Instructions	Cook Medical is advising customers to quarantine affected stock from their inventory for return to the sponsor for a product credit as per the instructions given in the customer letter. This action has been closed out on 25/01/2021
Contact Information	1800 777 222 - Cook Medical