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Recall Observatory FDA recall evidence

Device product

ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter

Z-0601-2018

July 25, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 78964
Status
Terminated
Classification
Class II
Quantity
2691 total
Official record key
device-enforcement:Z-0601-2018

Official wording

Reason: Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.

Code information: Lot/Batch Numbers: 23F17A0038, 23F17A0040, 23F16M0059.

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.