Arrow Two-Lumen Central Venous Catheterization Kit Recalled for Labeling Error
Arrow International Inc is recalling specific lots of Two-Lumen Central Venous Catheterization Kits because the lidstock displays an incorrect priming volume.
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 describes a minor labeling error with no reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Arrow International Inc is recalling specific lots of Arrow Two-Lumen Central Venous Catheterization Kits with Blue FlexTip Catheters. The recall is due to a labeling error on the product lidstock, which states an incorrect priming volume. The priming volumes printed on the extension lines are correct.
The affected product is identified by Product Code AH-11802 (OUS) and GTN 00801902026132. The recall covers specific lot numbers distributed in Florida and North Carolina. The source text does not specify the total number of units affected or the exact distribution dates.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. The labeling error on the lidstock may cause confusion regarding the correct priming volume, although the extension lines contain the correct information.
The recalled product
- Product
- Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
Distribution
Part of a larger recall action
This product is one of 2 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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