Arrow Radial Arterial Access Kits Recalled for Unsealed Packaging
Arrow International is recalling Radial Arterial Access Kits because unsealed packaging may compromise sterility. The recall covers 416,055 units distributed in the US and 33 other countries.
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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Radial Arterial Access Kits (Product Code: ASK-04001-BID2) due to a potential sterility issue. The recall is triggered by unsealed packaging, which may compromise the sterility of the medical devices.
The affected products were distributed nationwide in the United States as well as in 33 other countries, including Australia, Canada, the United Kingdom, and Germany. Specific lot numbers involved in the recall are 13F17A0195, 13F17D0213, 13F17F0428, 13F17K0314, and 13F17L0113.
Healthcare facilities and consumers should stop using these products and contact Arrow International Inc for further instructions or a return. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Radial Arterial Access Kit; Product Code: ASK-04001-BID2
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 416,055
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: 13F17A0195 13F17D0213 13F17F0428 13F17K0314 13F17L0113
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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