Argon Medical Devices Recalls BioPince Biopsy Instruments Due to Labeling Error
Argon Medical Devices is recalling BioPince Full Core Biopsy Instruments because of incorrect product labeling. The recall affects 165 units in the U.S. and 330 units internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to incorrect product labeling, which fits the rubric criterion for minor labeling errors and low-risk issues.
Plain-English summary
Argon Medical Devices, Inc. is recalling the BioPince Full Core Biopsy Instrument, 16ga x 15cm, due to incorrect product labeling. The affected product is a disposable, automatic instrument used to obtain multiple core samples from soft tissue such as the liver, kidney, and abdominal masses.
The recall involves 165 units distributed in the United States and 330 units distributed internationally. The specific lot number is 11277175, and the model number is 370-1580-01. Distribution in the U.S. included Texas, Illinois, Florida, Kansas, Maryland, California, Washington, New York, and Wisconsin. International distribution included the United Arab Emirates, Spain, and Canada.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected instruments and contact Argon Medical Devices for instructions on return or replacement.
The recalled product
- Product
- BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, abdominal ma
- Manufacturer
- Argon Medical Devices, Inc
- Hazard
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 (4)
- Lot No.: 11277175
- Model # 370-1580-01
- 16ga x 15cm
- for use with Optional Co-axial Needle MCXS1615BP
Distribution
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