Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore B...
FDA Recall #Z-1077-2021 — Class II — December 10, 2020
Product Description
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
Reason for Recall
Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
Recalling Firm
Argon Medical Devices, Inc — Athens, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
583 units
Distribution
US: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX,, UT, VA, WA, WI, WV, WY OUS: Switzerland, Saudi Arabia, Hong Kong, Thailand, Portugal, Taiwan, Austria, Brazil, Netherlands, Italy, Germany, Colombia, Singapore, Canada, View Nam, Slovakia, Spain
Code Information
Lot Number: 1394204, 1424962, 1464709, 1473181, 1477229, 1481735, 1495182
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated