Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01089-1
Product Name/Description	LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm Catalogue Number: 1601-38 Lot Number: SLC3663 ARTG Number: 147757
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	9/11/2015
Responsible Entity	Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue	LeMaitre Embolectomy Catheters are indicated for the removal of arterial emboli and thrombi. A small number of these products from the affected lot may have a compromised sterile barrier due to a packaging tube defect in the form of a pinhole at the sealed end of the packaging tube. The current IFU does not require inspection of the packaging prior to use and loss of product sterility could not be visually identified. The issue occurred due to fluctuations in the power sources for the sealing machine during the packaging tube manufacturing process. Loss of product sterility could lead to cross-contamination and infection. No complaints have been received relating to this issue.
Recall Action	Recall
Recall Action Instructions	Users are asked to inspect their stock and quarantine all affected units prior to their return to Emergo as per the instructions in the Customer Letter. This action has been closed-out on 18/08/2016.
Contact Information	(02) 9006 1662 - Emergo Australia