Z-1075-2021Class II

Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle...

Name: Z-1075-2021 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle...
Creator: Argon Medical Devices, Inc
Published: 2020-12-10
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2020-12-10 / Terminated / root cause: manufacturing process

FDA source

Argon Medical Devices, Inc began a recall of Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener... on 2020-12-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1075-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-10
Posted: 2021-02-05
Terminated: 2023-01-31
Recalling firm: Argon Medical Devices, Inc
Product: Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, Sterile EO,
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. You may also contact Ms. Arbee Cummings at [email protected] or Ms. Andrea Wieczor at [email protected].
Quantity in commerce: 247 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
Product codes and lots: Lot Number: 1439835,1451429, 1486445

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1075-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1072-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1073-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1074-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1075-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1076-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1077-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05

Product code DYB

K022634Class IICo-Axial Introducer NeedlePromex, Inc. / cleared 2002-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)