—#185021

Product

Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K022634
Affected lot / code info: Lot Number: 1428364, 1451428, 1486448

Why it was recalled

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 (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751-5002

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2020-12-10
Terminated: 2023-01-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.