Arrow Radial Artery Catheterization Kit Recalled for Packaging Defect
Arrow International 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility may be compromised, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling Radial Artery Catheterization Kits with Sharps Safety Features (Product Code: ASK-04120-HF) due to a potential sterility issue. The recall affects 416,055 units distributed in the United States and numerous international markets, including Australia, Canada, and the United Kingdom. The specific lot numbers involved are 13F17C0281 and 13F17G0398.
The recall was initiated because the product packaging may be unsealed, which could compromise the sterility of the medical device. This defect poses a risk of infection if the non-sterile product is used in a clinical setting.
Healthcare providers and facilities should check their inventory for the affected product code and lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Consumers are advised to contact their healthcare provider if they have had this specific product used on them.
The recalled product
- Product
- Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF
- Manufacturer
- Arrow International Inc
- 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: 13F17C0281 13F17G0398
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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