# FDA recall Z-1072-2021

> **Argon Medical Devices, Inc** · Class II · device recall initiated 2020-12-10.

## Product

Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF:  TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Catheter, 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.

## 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

## Key facts

- **Recall number:** Z-1072-2021
- **Recalling firm:** Argon Medical Devices, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-10
- **Report date:** 2021-02-17
- **Termination date:** 2023-01-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athens, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1072-2021

## Citation

> AI Analytics. FDA recall Z-1072-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1072-2021. Source: US FDA. Licensed CC0.

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