Arrow Central Venous Catheter Kits Recalled for Missing Clinical Documentation
Arrow International is recalling 18,124 central venous catheter kits because they lack required clinical guidance documents. The recall is nationwide.
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 involves missing documentation rather than a direct physical defect or contamination, fitting the criteria for moderate severity.
Plain-English summary
Arrow International Inc is recalling 18,124 units of the Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. The recall is due to the absence of the Central Venous Catheter Placement Procedures Note and the Central Line Insertion Checklist. These documents are intended to guide clinicians in using best practices during central line insertions.
The affected products were distributed nationwide. The specific product code is ASK-45802-PHMW 13F16K0236. The FDA has classified this as a Class II recall.
Healthcare facilities and consumers should check their inventory for this specific product code and stop using the affected kits. They should contact Arrow International Inc for further instructions on how to return or dispose of the products.
The recalled product
- Product
- Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 18,124
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)
- ASK-45802-PHMW 13F16K0236
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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