Argon Medical Devices Recalls ClosureFast Introducer Sheath Sets Due to Assembly Error
Argon Medical Devices is recalling specific ClosureFast Introducer Sheath Sets because incorrect sheath lengths were assembled to the devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a functional defect (incorrect sheath length) poses a risk of harm during invasive procedures, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Argon Medical Devices, Inc. is recalling approximately 2,000 units of ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm (REF MIS-F707) and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm (REF IS-7F11). These medical devices are indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
The recall was initiated because an assembly error resulted in incorrect sheath lengths being attached to the devices. Specifically, the size 7 products were assembled with 11 cm sheaths, and the size 11 products were assembled with 7 cm sheaths.
The affected products were distributed in Illinois. The specific lots involved are Lot 1125585 for the MIS-F707 and Lot 11126021 for the IS-7F11. Healthcare providers and facilities should stop using these specific lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
- Manufacturer
- Argon Medical Devices, Inc
- Affected units
- 2,000
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 (1)
- Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11)
Distribution
Distributed in 1 state:
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