FDA Medical Device Recalls (openFDA)
Argon Medical Devices, Inc: 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
- Recall number
- Z-1072-2021
- Recalling firm
- Argon Medical Devices, Inc
- 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,
- Status
- Terminated
- Initiated
- 2020-12-10
- Posted
- not on file
- Terminated
- 2023-01-31
- 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.
- Root cause
- Process change control
- Action
- On 12/11/2020, Argon Medical Devices, Inc. distributed an "Urgent-Product Recall Notice" to all affected consignees via US mail. In addition to informing consignees about the recall device, the firm ask consignees to take the following actions: 1. Complete the response form and return it to us as quickly as possible. This will allow us to begin staging replacement product for you and minimize interruption to service. 2. All affected product should be returned to our Argon Athens facility using RGA#______, attention Arbee Cummings. The mailing address is as follows: RGA# ____, Argon Medical Devices, Inc.1445 Flat Creek Road, Athens, TX 75751 USA 3. Argon Medical will ship your replacement devices as soon as we receive your returned product. Your assistance in accounting for the affected devices in your possession is greatly appreciated. If you have any questions about this letter or about the recall action it describes, please contact Beckie.Ellis@argonmedical.com. You may also contact Ms. Arbee Cummings at Arbee.Cummings@argonmedical.com or Ms. Andrea Wieczor at Andrea.Wieczor@argonmedical.com.
- Quantity
- 483 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
- Lot, serial or model codes
- Lot Number: 1419196, 1460291, 1469844, 1502325
- 510(k) numbers
- ["K022634"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1625425
- Firm city
- Athens
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28