Arrow International Recalls Epidural Anesthesia Kits with Incorrect Syringe Components
Arrow International is recalling 300 units of an epidural anesthesia kit because the kit contains a Luer-Lock syringe instead of the labeled Luer-Slip syringe.
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 component mismatch (Luer-Lock vs. Luer-Slip) without reporting any illnesses, injuries, or specific functional failures, fitting the criteria for a moderate severity labeling or component error.
Plain-English summary
Arrow International, Inc. is recalling 300 units of the ASK-05501-AFH1 Anesthesia Conduction Catheter, Epidural Anesthesia Kit, Lot Number 23F13K0969. The recall was initiated because the product contains an incorrect component. Specifically, the lidstock indicates that the kit contains one 10mL Luer-Slip Loss of Resistance Glass Syringe, but the kit actually contains one 10mL Luer-Lock Loss of Resistance Glass Syringe.
The affected products were distributed in Utah only. The FDA has classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Customers who have purchased or received this specific lot number should stop using the product and contact Arrow International, Inc. for instructions on how to return the product for a refund or replacement.
The recalled product
- Product
- ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
- Manufacturer
- Arrow International Inc
- Affected units
- 300
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)
- Catalog No. ASK-05501-AFH1 Lot Number 23F13K0969
Distribution
Distributed in 1 state:
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