Arrow PICC Recall Due to Potential Incorrect Peel-Away Sheath Size
Arrow International is recalling specific lots of ARROW PICC powered by ARROW VPS Stylet kits that may contain 5 Fr peel-away sheaths instead of the required 4 Fr.
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, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Arrow International Inc. is recalling specific lots of 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 product 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 central venous pressure monitoring. The recall involves lot number 23F16M0263.
The product was distributed nationwide to Arizona, California, Massachusetts, Missouri, North Carolina, New York, Oregon, and South Dakota. Healthcare facilities and consumers should check their inventory for this specific lot number and discontinue use if found.
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 — Vascular Access
- 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: 23F16M0263
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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