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Recall Observatory FDA recall evidence

Device product

Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days

Z-0004-2024

August 10, 2023

Class I

Product summary

Firm
ARROW INTERNATIONAL Inc.
Event
Event 93014
Status
Ongoing
Classification
Class I
Quantity
172 units
Official record key
device-enforcement:Z-0004-2024

Official wording

Reason: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

Code information: Batch/Lot number 13F22G0508

Distribution pattern: US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.