FDA Device recall Z-1074-2021
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 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 - 19N, 1/19 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-1074-2021 |
| 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 - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 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: 1439836, 1451430, 1486441 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1074-2021%22
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