Arrow International Recalls Hemodialysis Catheterization Kits
Arrow International Inc. is recalling ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kits due to a Class II recall.
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 is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report specific injuries or illnesses, placing this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc. is recalling the ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions. The recall is classified as Class II by the U.S. Food and Drug Administration. The product is identified by material number CDA-22122-U1A and was distributed nationwide.
The source text describes the catheter as a large-bore two-lumen device intended for short-term central venous access, rapid fluid administration, and hemodialysis. It notes that the ARROWg+ard Blue antimicrobial surface is designed to help provide protection against catheter-related infections resulting from microorganisms migrating along the exterior surface of the catheter. However, the text states that clinical data have not been collected demonstrating that the antimicrobial surface decreases catheter-related infections in hemodialysis patients. The catheter is not intended to treat existing infections or for long-term use.
The source text does not specify the exact reason for the recall, the number of units affected, or specific dates of distribution. Consumers and healthcare providers should contact Arrow International Inc. or their local FDA office for further instructions on how to handle the recalled product.
The recalled product
- Product
- ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Hazard
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)
- Material number CDA-22122-U1A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 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.
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