Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Argon Medical Devices TLAB Recalled by Argon Medical Devices, Inc Due to Due to a manufacturing error their is a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Argon Medical Devices, Inc directly.
Affected Products
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,
Quantity: 863 unit
Why Was This 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.
Where Was This Sold?
This product was distributed to 45 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, WY, DC
About Argon Medical Devices, Inc
Argon Medical Devices, Inc has 42 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report