Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: ...
FDA Recall #Z-1365-2019 — Class II — December 13, 2018
Product Description
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.
Reason for Recall
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
Recalling Firm
Arrow International Inc — Reading, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
963 units (US) in total
Distribution
US Nationwide Distribution
Code Information
Lot /Batch Number: 23F18F0005, 23F18B0583 GTN:40801902120753
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated