Arrow International Recalls Pressure Injectable PICC Kits Due to Sheath Error
Arrow International Inc. is recalling specific lots of ADVANTAGE 5" Pressure Injectable PICC kits because they may contain 5 Fr peel-away sheaths instead of the required 4 Fr sheaths.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a component mismatch (5 Fr vs 4 Fr sheath) which is a quality control issue without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc. is recalling specific lots of ADVANTAGE 5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) 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 is classified as Class II by the U.S. Food and Drug Administration.
The affected lot number is 23F16L0021. The products were distributed nationwide to Arizona, California, Massachusetts, Missouri, North Carolina, New York, Oregon, and South Dakota. Healthcare providers and facilities should check their inventory for this specific lot number and stop using the affected kits.
The recalled product
- Product
- ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) 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
- 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: 23F16L0021
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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