FDA-Device2023-10-11Class I

Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days

ARROW INTERNATIONAL Inc.
Hazard

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

Sold states
US
Affected count
180 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2024

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