Arrow PICC Kits Recalled for Potential Incorrect Sheath Size
Arrow International is recalling specific PICC kits that 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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a component size discrepancy (5 Fr vs 4 Fr sheaths) without reported injuries or deaths, fitting the Moderate category for low-risk contamination or labeling/component errors.
Plain-English summary
Arrow International Inc is recalling ARROW PICC powered by ARROW VPS Stylet kits. 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 for the recalled items is 23F16K0055.
Healthcare providers and facilities should check their inventory for this specific lot number and stop using the affected kits. Users should contact Arrow International for further instructions or replacement products.
The recalled product
- Product
- ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure m
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- 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 Number: 23F16K0055
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.
See all 4 products in this recall →Related recalls
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