The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2806-2020·Announced 2020-08-26

Argon Medical Devices Recalls ClosureFast Micro Introducer Sheath Sets

Argon Medical Devices is recalling 1,000 units of ClosureFast Micro Introducer Sheath Sets because the sterile products were manufactured under one lot with different expiration dates.

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 2/5 (Moderate).

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, but the source text describes a manufacturing discrepancy regarding expiration dates without reporting any illnesses, injuries, or specific clinical hazards. This aligns with the rubric for moderate severity involving labeling or documentation issues.

Plain-English summary

Argon Medical Devices, Inc. is recalling 1,000 units of the ClosureFast Micro Introducer Sheath Set (REF MIS-7F11). The affected products are sterile, ethylene oxide (EO) sterilized, and intended for prescription use only. These introducer products are used to facilitate access to a vein or artery, allowing various catheters to be passed through for local or central diagnostic or therapeutic interventions.

The recall was initiated because the sterile introducer sheath sets were manufactured under one lot (LOT 11295042) with different expiration dates. This discrepancy in expiration dates within a single lot number is the specific reason for the recall.

The affected products were distributed nationwide in the United States, including in the state of Mississippi. Consumers and healthcare providers should check their inventory for the specific product reference MIS-7F11 and lot number 11295042. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or…
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Introducer Sheath
Hazard
Affected units
1,000

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 11295042

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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