Argon Medical Devices Recalls Transjugular Liver Biopsy System Due to Sheath Separation
Argon Medical Devices is recalling the TLAB Transjugular Liver Biopsy System because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and the source text explicitly states the defect could result in permanent damage to a body structure or permanent impairment of a body function, which aligns with the rubric criteria for Severe severity (significant injury reports or potential for permanent impairment).
Plain-English summary
Argon Medical Devices, Inc. is recalling 187 units of the TLAB Transjugular Liver Biopsy System (REF: TL-19N). The affected units include a 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath with Curved Metal Stiffener, and 4 Tissue Removal Swabs. The recall involves lot numbers 1439836, 1451430, and 1486441.
The recall is due to a manufacturing error that creates a potential for the sheath within the biopsy kit to separate during use if the tip is flexed or experiences bending stresses. This defect could result in the need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
The affected products were distributed in the United States (including 45 states, DC, and Puerto Rico) and internationally to countries including Switzerland, Saudi Arabia, Hong Kong, Thailand, Portugal, Taiwan, Austria, Brazil, Netherlands, Italy, Germany, Colombia, Singapore, Canada, Vietnam, Slovakia, and Spain. Healthcare facilities and consumers should stop using the affected devices and contact Argon Medical Devices for further instructions.
The recalled product
- Product
- 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,
- Manufacturer
- Argon Medical Devices, Inc
- Category
- Medical Device — Biopsy System
- Affected units
- 187
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Number: 1439836
- 1451430
- 1486441
Distribution
Part of a larger recall action
This product is one of 6 recalled by Argon Medical Devices, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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