Arrow International Recalls Central Venous Catheter Kits Due to Sterility Concerns
Arrow International is recalling 416,055 central venous catheter 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. The hazard is a potential sterility compromise due to packaging issues, which is a significant risk but does not meet the criteria for Severe (Class I or reported hospitalization) or High (high-risk pathogens without illness). It fits the Moderate category for a Class II recall without reported adverse events.
Plain-English summary
Arrow International Inc is recalling 416,055 units of the Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features (Product Code: ASK-45802-PHMW). The recall was initiated because product sterility may be compromised due to unsealed packaging.
The affected products are identified by the following lot numbers: 13F17E0141, 13F17E0300, 13F17H0147, and 13F17J0336. These products were distributed nationwide in the United States and in 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 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. No specific instructions for consumer action are provided in the source text beyond the identification of the affected lots.
The recalled product
- Product
- Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 416,055
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 13F17E0141 13F17E0300 13F17H0147 13F17J0336
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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