Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues
Arrow International is recalling 416,055 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 is a potential sterility compromise due to packaging defects. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Arrow International Inc is recalling 416,055 units of the Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter. The recall is being conducted because product sterility may be compromised due to unsealed packaging.
The affected product is identified by Product Code ASK-15703-LDP1. Specific lot numbers involved in this recall include 13F17B0389, 13F17E0430, 13F17F0580, 13F17H0545, 13F17K0403, and 13F17L0285.
The products were distributed in the United States and internationally, including Australia, Austria, Belgium, Canada, and numerous other countries. Healthcare facilities and consumers should check their inventory for the specific lot numbers listed and stop using the affected products.
The recalled product
- Product
- Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LDP1
- 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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