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Product Recall Notice

Dec 14, 2020

Argon Medical Devices, Inc. (“Argon”) has received complaints from customers regarding the TLAB Transjugular Liver Biopsy System for a potential defect of the 7F Introducer Sheath, where the distal tip can potentially separate during use if the tip is flexed or experiences lateral bending stresses. Argon has conducted an internal investigation and has determined that an error in the production process resulted in a small number of devices that could have this defect. Actions have already been identified and implemented to improve the process.

As a precautionary measure, Argon is conducting a recall to notify all customers of the potential separation of the 7F Introducer Sheath distal tip that is included in certain TLAB kits.

If you are in possession of a device listed below, please read the attached notice and reach out to Terumo Medical Canada Inc. for handling.

 

Item Number

Lot/Serial

Qty

TL-18C

1394204

24

TL-18N

1419198

1

TL-18C

1464709

28

TL-18N

1467762

8

TL-19N

1451430

2

TL-19

1428364

24

TL-18C

1473181

46

TL-18C

1481735

4

TL-18C

1495182

19

TL-18N

1473975

14

TL-18S

1469844

2

 

Total

172

 

 

Argon - TLAB Product Recall Notice
View Argon - TLAB Product Recall Notice