FDA-Device2023-09-27Class II

Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter

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 Nationwide distribution.
Affected count
177 units
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2591-2023

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