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Recall Observatory FDA recall evidence

Device product

ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet

Z-0690-2018

October 17, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 79200
Status
Terminated
Classification
Class II
Quantity
601 eaches
Official record key
device-enforcement:Z-0690-2018

Official wording

Reason: The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.

Code information: CDC 34041 VPS Lot# 23F17A0037 23F17B0035

Distribution pattern: AZ, CA, GA, MA, MO, NY, VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.