Arterial Line Kits recalled due to guidewire-needle incompatibility
Argon Medical Devices is recalling Arterial Line Kits because the included guidewires don't fit through the kit's needles. This could cause procedure delays and minor blood loss.
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: FDA Class II medical device with no reported illnesses or injuries, but the guidewire-needle incompatibility creates risk of procedural delay and blood loss in critical medical settings, fitting the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Argon Medical Devices, Inc is recalling two lots of Arterial Line Kits due to a guidewire incompatibility issue. The affected kits are Model 400115A (Serial 11377499, expiring 10/27/2022) and Model 498100 (Serial 11378381, expiring 4/15/2026). Approximately 600 units were distributed nationwide to facilities in Alabama, California, Delaware, Illinois, Indiana, Louisiana, Montana, Nevada, Ohio, Texas, Virginia, and Tennessee.
The guidewires included with the kits do not fit through the needles of the same kits. This incompatibility could potentially lead to a delay in the medical procedure and minor blood loss during arterial line placement.
No illnesses or injuries have been reported in connection with this issue. Healthcare facilities should discontinue use of the affected kits and contact Argon Medical Devices for further instructions.
The recalled product
- Product
- 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
- Manufacturer
- Argon Medical Devices, Inc
- Affected units
- 600
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)
- 1. Model: 400115A and Serial # 11377499
- Expire Date: 10/27/2022 2. Model: 498100 and Serial # 11378381
- Expire Date: 4/15/2026
Distribution
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