Arrow International Inc: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

Agency Publication Date: November 28, 2017

Affected Products

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 is to the cavo-atrial junction near the sino-atrial node

Lot/Batch Numbers: 23F16M0017

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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 monitoring

Lot/Batch Number: 23F16M0263

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Lot/Batch Number: 23F16K0055

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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 and allows for central venous pressure monitoring

Lot/Batch Number: 23F16L0021

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77589

Status: Resolved

Manufacturer: Arrow International Inc

Manufactured In: United States

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot/Batch Numbers: 23F16M0017

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Lot/Batch Number: 23F16M0263

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Lot/Batch Number: 23F16K0055

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Lot/Batch Number: 23F16L0021

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