Arrow Radial Artery Catheterization Set Recalled for Foreign Matter
Arrow International Inc is recalling Radial Artery Catheterization Sets due to the presence of loose polypropylene foreign matter above release specifications.
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 the hazard involves foreign matter contamination without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Arrow International Inc is recalling specific lots of Radial Artery Catheterization Sets (models NA-04550-1A and NA-04550-X1A). The recall was initiated after the needle supplier indicated the presence of loose polypropylene foreign matter that exceeded release specifications.
The affected products are identified by Lot Numbers 23F16H0859 and 23F16J0547. These devices are used to permit access to the peripheral arterial circulation or other small vessels.
Healthcare facilities and distributors should stop using the affected lots and contact Arrow International Inc for further instructions or returns.
The recalled product
- Product
- Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
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 Numbers: 1) 23F16H0859 & 2) 23F16J0547
Distribution
Distribution scope not specified by the agency.
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