Arrow International Recalls Central Venous Catheterization Kits Due to Packaging Issues
Arrow International Inc. is recalling 416,055 Multi-Lumen Central Venous Catheterization 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, and the hazard is a theoretical risk of compromised sterility due to packaging issues with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc. is recalling 416,055 units of the Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions (Product Code: ASK-42703-RV1). The recall is being conducted because product sterility may be compromised due to unsealed packaging.
The affected products were distributed in the US Nationwide and in numerous international locations, including Australia, Austria, Belgium, Canada, and the United Kingdom. The specific lot numbers involved in this recall are 13F17B0020, 13F17B0269, 13F17C0303, 13F17F0317, 13F17H0062, 13F17J0386, 13F17K0583, and 13F17L0455.
Healthcare facilities and consumers should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- 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.
See all 76 products in this recall →Related recalls
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