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.
What this means for you
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: (01)10801902212099(17)270731(11)25121
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Hazard
- manufacturing-defect
- adhesive-integrity
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- ModerateMedtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27