Arrow Central Venous Catheterization Kit Recalled for Incorrect Expiration Date
Arrow International Inc is recalling 140 units of Central Venous Catheterization Kits 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 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 140 units of the Arrow Central Venous Catheterization Kit, model ASK-04200-UPM. The recall was initiated because the product lidstock contains the incorrect expiration date for the product.
The affected units are identified by Lot Number 13F18H0209. The product was distributed nationwide and in the following foreign countries: AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA.
This is a Class II recall. Consumers and healthcare providers should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- Arrow Central Venous Catheterization Kit ASK-04200-UPM
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 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)
- Lot Number: 13F18H0209
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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