Arrow Radial Artery Catheterization Kit Recalled for Unsealed Packaging
Arrow International Inc is recalling Radial Artery Catheterization Kits because unsealed packaging may compromise product sterility.
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 potential sterility compromise due to packaging issues, which fits the criteria for moderate severity involving low-risk contamination or precautionary measures without reported injuries.
Plain-English summary
Arrow International Inc is recalling Radial Artery Catheterization Kits with Sharps Safety Features (Product Code: ASK-04020-RIHM). The recall involves 416,055 units distributed in the United States and numerous international locations, including Australia, Canada, and the United Kingdom.
The recall was initiated because product sterility may be compromised due to unsealed packaging. The affected lot numbers are 13F17C0179, 13F17E0655, 13F17G0301, 13F17H0284, 13F17K0566, and 13F17M0019.
Healthcare facilities and consumers should stop using these products and contact Arrow International Inc for further instructions or a return.
The recalled product
- Product
- Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
- Manufacturer
- Arrow International Inc
- Affected units
- 416,055
Distribution
Part of a larger recall action
This product is one of 76 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 76 products in this recall →Related recalls
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