FDA-Device2021-02-17Class II
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
Hazard
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.
Sold states
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
Affected count
187 units
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
Products
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1074-2021More Argon Medical Devices, Inc recalls
- FDA-Device2026-07-22Argon Medical Devices General Biopsy Tray recalled for sterility concerns
- FDA-Device2026-07-22Argon Medical Devices Arterial Line Kit recalled for sterility test failure
- FDA-Device2026-07-22Argon Medical Devices pacing electrode trays recalled for sterility failure in lidocaine ampules
- FDA-Device2026-07-22Argon Medical Devices One-Piece Introducer Tray recalled for sterility failure in Lidocaine ampules
- FDA-Device2026-07-22Argon Medical Devices T-Lok Bone Marrow Tray recalled for sterility failure
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