Arrow Epidural Catheterization Kit Recalled for Incorrect Expiration Date
Arrow International Inc is recalling 1,760 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. The hazard is a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Arrow International Inc is recalling 1,760 units of the Arrow Epidural Catheterization Kit (JH-05500). The recall was initiated because the product lidstock contains the incorrect expiration date for the product.
The affected units are identified by Lot Number 13F18A0719. The products were distributed nationwide and to foreign countries including AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA.
Consumers and healthcare facilities should stop using the affected products and contact Arrow International Inc for further instructions.
The recalled product
- Product
- Arrow EPIDURAL CATHETERIZATION KIT JH-05500
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 1,760
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: 13F18A0719
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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