Argon Medical Recalls Arterial Access Needles Due to Packaging Defect
Argon Medical Devices is recalling specific arterial access needles due to a potential packaging defect involving unsealed pouches.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a packaging-only problem (unsealed pouch) with no reported injuries or illnesses, fitting the 'Low' severity criteria for cosmetic or packaging defects.
Plain-English summary
Argon Medical Devices, Inc. is recalling specific models of Arterial Access Needles, including Clear Flashback Needles and Winged Arterial Needles, due to a potential packaging defect. The defect involves a potential void or unsealed edge on the product's sealed pouch.
The recall was initiated after the company received a complaint from a distributor regarding this packaging issue. The affected products are designed to provide vascular access for the percutaneous introduction of a guidewire.
The recall covers 7,140 pieces of the affected needles. Distribution was worldwide, including the United States, Belgium, Canada, Japan, and the Netherlands. Affected lot codes include 11161099, 11161729, 11160990, and 11160912.
The recalled product
- Product
- Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction…
- Manufacturer
- Argon Medical Devices, Inc
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 7,140
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)
- 11161099 11161729 11160990 11160912
Distribution
Distributed nationwide across the United States.
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