Arrow AGB+ Multi-Lumen CVC Kit Recalled for Labeling Error
Arrow International Inc. is recalling 1,705 kits due to a potential product code mislabeling that could cause delays or allergic reactions in sensitive patients.
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 hazard involves a labeling error that could lead to minor delays or allergic reactions in patients with specific sensitivities, fitting the criteria for moderate severity without reported serious injuries.
Plain-English summary
Arrow International Inc. is recalling 1,705 units of the Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen (Product Code: CDC-45703-1A). The recall is due to a labeling error where the banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and fail to identify the product as a coated ARROWg+ard Blue PLUS (AGB+) antimicrobial catheter.
The lidstock and information card on the kits correctly state the product code as CDC-45703-1A. The mislabeling may cause a minor delay during use and placement. Additionally, placing a coated catheter in patients with known sensitivity to chlorohexidine, silver sulfadiazine, or sulfa could result in an allergic reaction.
The affected units are distributed US Nationwide. The specific lot code is 13F20E0173. Consumers and healthcare providers should check the banner card on the side of the kit for the incorrect product code CDC-15703-1A.
The recalled product
- Product
- Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 1,705
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)
- Lot Code: 13F20E0173
Distribution
Distributed nationwide across the United States.
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