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Recall Observatory FDA recall evidence

Device product

Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days

Z-0003-2024

August 10, 2023

Class I

Product summary

Firm
ARROW INTERNATIONAL Inc.
Event
Event 93014
Status
Ongoing
Classification
Class I
Quantity
380 units
Official record key
device-enforcement:Z-0003-2024

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 13F22L0806

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.