Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number: 1439836, 1451430, 1486441
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Argon Medical Devices, Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
Product Codes/Lot Numbers:
Lot Number: 1439836, 1451430, 1486441
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1074-2021
Related Recalls
Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied
Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.
L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Argon Medical Devices
Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay.