Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues
Arrow International is recalling specific central venous catheterization kits because unsealed packaging may compromise product sterility.
What this means for you
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 involves potential sterility compromise due to packaging issues without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Arrow International Inc is recalling 416,055 Multi-Lumen Central Venous Catheterization Kits with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. The affected product codes are ASK-42703-MHW and ASK-42703-OLL1. The recall is being conducted because product sterility may be compromised due to unsealed packaging.
The affected lots include 13F16M0282, 13F17D0183, 13F17H0260, and 13F17M0344 for product code ASK-42703-MHW, and 13F17C0293, 13F17E0414, and 13F17J0243 for product code ASK-42703-OLL1. 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 check their inventory for these specific product codes and lot numbers. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1
- 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.
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