FDA Device recall Z-1076-2021
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curve…
- FDA Device
- Class II
- terminated
- Published 2021-02-17
On 2021-02-17 the FDA classified a Class II recall of Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curve… by Argon Medical Devices, citing 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 re….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1076-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-10 |
| Published | 2021-02-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Argon Medical Devices |
| Distribution | 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 |
Product
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, 1/5F Curved Catheter Sterile EO,
Reason
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.
Identifiers
| code_info | Lot Number: 1394204, 1424962, 1464709, 1473181, 1477229, 1481735, 1495182 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Argon Medical Devices
- L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539
FDA Device · Class II · 2026-08-05 · Argon Medical Devices - L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
FDA Device · Class II · 2026-08-05 · Argon Medical Devices - General Biospy Tray, REF: GUTS1000
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - Arterial Line Kit 20ga x 6, REF: 400115A
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
FDA Device · Class I · 2026-07-22 · Argon Medical Devices
All Argon Medical Devices recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1076-2021%22
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