Arrow International Recalls Central Venous Catheter 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.
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 a potential sterility compromise due to packaging defects without 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 due to a defect where product sterility may be compromised by unsealed packaging.
The affected products were distributed in the United States and numerous international locations, including Australia, 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 stop using these products immediately and contact Arrow International Inc for instructions on how to return or dispose of the affected kits.
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.
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