Arrow VPS Access Kit Recalled for Potential Size Mismatch
Arrow International is recalling VPS Access Kits because they may contain 5 Fr peel-away sheaths instead of the required 4 Fr size.
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 source text describes a potential component mismatch without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc is recalling the Arrow VPS Access Kit for use with 4 Fr Peripherally Inserted Central Venous Catheter. The recall is due to a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
The affected products were distributed nationwide to Arizona, California, Massachusetts, Missouri, North Carolina, New York, Oregon, and South Dakota. The specific lot number involved is 23F16M0017.
The VPS System is intended to guide peripherally inserted central catheters (PICCs) to the cavo-atrial junction. Users should stop using the affected kits and contact the manufacturer for instructions.
The recalled product
- Product
- Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which
- Manufacturer
- Arrow International Inc
- Hazard
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/Batch Numbers: 23F16M0017
Distribution
Part of a larger recall action
This product is one of 4 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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