Arrow Arterial Catheterization Kit Recalled for Unsealed Packaging
Arrow International Inc. is recalling Arterial 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 risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Arrow International Inc. is recalling Arterial Catheterization Kits (Product Code: NA-04550-1A) due to a potential sterility issue. The recall is being conducted because the product packaging may be unsealed, which could compromise the sterility of the medical device.
The recall affects 416,055 total products distributed in the United States and numerous international locations, including Australia, Canada, and the United Kingdom. Specific lot numbers involved in the recall are 13F17B0315, 13F17C0033, 13F17C0462, 13F17F0145, 13F17F0550, 13F17G0229, 13F17H0049, and 13F17H0328.
Healthcare facilities and consumers should check their inventory for the affected lot numbers and stop using the recalled products. Users should contact Arrow International Inc. for further instructions on how to return or dispose of the recalled kits.
The recalled product
- Product
- Arterial Catheterization Kit; Product Code:NA-04550-1A
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Hazard
- 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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