FDA-Device2023-10-11Class I
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
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
172 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0004-2024Don't want to check this manually?
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