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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00772-1
Product Name/Description	Arista AH FlexiTip XL-R Applicator Catalog Number: AM0010 Lot Numbers: 6468501, 6539201, 6579301, 6666101, 8002101, 8036001, 8042301, 8071101, 8085701, 8085701, 8133202, 8189201 ARTG 258012 (Bard Australia Pty Ltd - Atomizing surgical topical solution applicator)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	29/08/2024
Responsible Entity	Bard Australia Pty Ltd
Reason/Issue	BD identified through one (1) complaint that certain lots may not release the Arista hemostatic powder from the Arista FlexiTip XL-R Applicator during use in surgical procedures. There has been no adverse event worldwide related to this issue.
Recall Action	Recall
Recall Action Instructions	Required actions for users: 1. Immediately discontinue use. 2. Please check all inventory locations for the affected product and immediately dispose of it. 3. Complete the Customer Acknowledgment Form ado BD may process any applicable credit regarding impacted product, confirming that affected product was disposed of. BD is investigating the issue and will implement corrective actions to prevent recurrence of the issue. BD will issue credits for impacted stock that is disposed of.
Contact Information	1800 656 100 - Bard Australia