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Type of Product	Medical Device
TGA Recall Reference	RC-2019-RN-00673-1
Product Name/Description	Zenith Alpha Abdominal Endovascular Graft Reference Part Numbers: ZIMB-26-84, ZIMB-24-84, ZIMB-26-98, ZIMB-28-118 Order Numbers: G35999, G35993, G36030, G34388 Lot Numbers: 9232391, 9232392, 9246536, 9232393, 9226426 ARTG: 265762 (William A Cook Australia Pty Ltd - Zenith Alpha Abdominal Endovascular Graft - Main Body - Graft, vascular, synthetic)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	30/04/2019
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	Cook Medical advises that Specific lots of the Zenith Alpha Abdominal Endovascular Graft may contain a damaged grey safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instruction for Use. Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention. Devices already implanted are not affected by this recall action.
Recall Action	Recall
Recall Action Instructions	Cook Medical is advising customers to quarantine and return affected stock. Affected product should be clearly marked with the QCR reference number QCR-95 upon return. This action has been closed out on 23/09/2019
Contact Information	1800 777 222 - Cook Medical Customer Relations