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Recall Observatory FDA recall evidence

Device 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.

Z-1365-2019

December 13, 2018

Class II

Product summary

Firm
Arrow International Inc
Event
Event 82506
Status
Terminated
Classification
Class II
Quantity
963 units (US) in total
Official record key
device-enforcement:Z-1365-2019

Official wording

Reason: 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

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

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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