Z-1365-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2019
- Initiation Date
- December 13, 2018
- Termination Date
- October 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 963 units (US) in total
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
Distribution Pattern
US Nationwide Distribution
Code Information
Lot /Batch Number: 23F18F0005, 23F18B0583 GTN:40801902120753