Arrow International Recalls CVC Kits Due to Unsealed Packaging
Arrow International is recalling 416,055 ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC 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 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. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a theoretical compromise of sterility due to packaging, which aligns with the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc is recalling 416,055 units of the ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit, Product Code CDC-42802-P1A. The recall is due to a defect where product sterility may be compromised by unsealed packaging.
The affected lots are 13F17B0333, 13F17C0338, 13F17D0322, 13F17E0539, 13F17E0870, 13F17F0116, 13F17H0136, 13F17J0024, 13F17K0268, 13F17L0062, 13F17L0207, and 13F17L0397. These products were distributed in the United States and numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and South America.
Healthcare facilities and consumers should stop using these specific kits and contact Arrow International Inc for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A
- Manufacturer
- Arrow International Inc
- 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.
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