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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