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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00145-1
Product Name/Description AnastoClip AC Closure System

Catalogue Number: 4012-02
Lot Numbers: EAV1023 (Expiry Dec. 2020), EAV1032 (Expiry Sept. 2021)

Catalogue Number: 4012-03
Lot Number: EAV1016 (Expiry 28 Oct. 2020)

ARTG Number: 120976
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 3/02/2017
Responsible Entity Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue The manufacturer, LeMaitre Vascular has identified that the box labels for certain lots of catalogue numbers 4012-02 and 4012-03 have an incorrect dimension listed. The box label for each size device illustrates a clip gap that is smaller by 0.3mm – 0.5mm than the actual clip of each size product. The IFU and Tyvek labels for the product have the correct size of the clip gap noted for each size. There have been no complaints about this issue.
Recall Action Recall
Recall Action Instructions Emergo is advising customers that all affected product should be returned for replacement. This action has been closed-out on 06/07/2017.
Contact Information 02 9006 1662 - Emergo Australia