Arrow International Recalls Hemodialysis Catheterization Kits
Arrow International Inc is recalling specific hemodialysis catheterization kits due to a lack of clinical data supporting the antimicrobial surface's effectiveness in preventing infections.
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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is based on the lack of clinical data supporting the product's antimicrobial claims rather than a confirmed defect causing harm, fitting the criteria for a moderate severity precautionary recall.
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 involves material number CDA-22122-U1A. The firm reports that a total of 43,394 devices were distributed nationwide.
The recall is initiated because clinical data have not been collected to demonstrate that the ARROWg+ard Blue antimicrobial surface decreases catheter-related infections in hemodialysis patients. The catheter is indicated for short-term central venous access and is not intended to treat existing infections or for long-term use.
Healthcare providers and patients should stop using the affected catheterization kits and contact Arrow International Inc for further instructions or replacement devices.
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 — Catheters
- Affected units
- 43,394
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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