Arrow International Inc: Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC

Agency Publication Date: May 16, 2019

Affected Products

Product: Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.

Lot /Batch Number: 23F18F0005, 23F18B0583 GTN:40801902120753

Lot Numbers:

Number

Product: Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.

Lot/Batch Number: 23F18B0581 GTIN:20801902120704

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82506

Status: Resolved

Manufacturer: Arrow International Inc

Manufactured In: United States

Units Affected: 2 products (963 units (US) in total)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot /Batch Number: 23F18F0005, 23F18B0583 GTN:40801902120753

Lot Numbers:

Number

Lot/Batch Number: 23F18B0581 GTIN:20801902120704

Lot Numbers:

Number