Arrow Epidural Catheterization Kit Recalled for Incorrect Expiration Date
Arrow International Inc. is recalling 1,320 units of the Arrow Epidural Catheterization Kit because the product lidstock contains the incorrect expiration date.
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 and involves a minor labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the 'Moderate' severity criteria for low-risk contamination or labeling issues.
Plain-English summary
Arrow International Inc. is recalling 1,320 units of the Arrow Epidural Catheterization Kit (AM-05500). The recall is due to a labeling error where the product lidstock contains the incorrect expiration date for the product.
The affected product is identified by Lot Number 13F18A0745. The recall is classified as Class II by the U.S. Food and Drug Administration. Distribution was nationwide and included foreign markets in AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA.
Consumers and healthcare facilities should check their inventory for this specific lot number and stop using the product if the expiration date on the lidstock is incorrect. They should contact Arrow International Inc. for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Arrow EPIDURAL CATHETERIZATION KIT AM-05500
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 1,320
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 Number: 13F18A0745
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 20 products in this recall →Related recalls
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