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Recall Observatory FDA recall evidence

Device product

Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter

Z-0001-2024

August 10, 2023

Class I

Product summary

Firm
ARROW INTERNATIONAL Inc.
Event
Event 93014
Status
Ongoing
Classification
Class I
Quantity
1173 units
Official record key
device-enforcement:Z-0001-2024

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 33F23B0781

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.