Arrow Radial Artery Catheterization Kit recalled for incorrect adhesive
Arrow International is recalling Arrow Radial Artery Catheterization Kits due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 675 units distributed nationwide.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing defect in liquid adhesive that is theoretical rather than confirmed to cause adverse health consequences. Per the rubric, Class II recalls without hospitalization reports typically score 2 (Moderate), and the absence of reported harm limits the score further.
Plain-English summary
Arrow International, LLC is recalling specific batches of the Arrow Radial Artery Catheterization Kit due to a supplier manufacturing defect. The liquid adhesive used in the kit was incorrectly manufactured, which could affect the device's integrity and function.
The affected product codes and batch numbers are: ASK-04220-UCL1 (Batch 33F25J0352), ASK-04020-EUH2 (Batch 33F25J0869), ASK-04020-FMC (Batch 33F25J0870), and ASK-04020-MMC (Batch 33F25J0880). A total of 675 units were distributed nationwide to healthcare facilities in Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania, and Virginia.
The Arrow Radial Artery Catheterization Kit is used to provide access to the peripheral arterial circulation and other small vessels. Healthcare providers should stop using affected units and contact Arrow International or the FDA for instructions on product disposal or replacement. Patients who have received treatment with a potentially affected device should consult their healthcare provider.
The recalled product
- Product
- ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code…
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 675
Distribution
Part of a larger recall action
This product is one of 8 recalled by ARROW INTERNATIONAL, LLC 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.
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