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Recall Observatory FDA recall evidence

Device product

Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.

Z-1494-2014

March 24, 2014

Class II

Product summary

Firm
Arrow International Inc
Event
Event 67831
Status
Terminated
Classification
Class II
Quantity
789
Official record key
device-enforcement:Z-1494-2014

Official wording

Reason: Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter.

Code information: lot #23F14A0375

Distribution pattern: Nationwide Distribution- Including the states of Az, Tn, Fl, Ga, Ca

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter.