PlainRecalls
FDA Devices Critical Class I Ongoing

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

Reported: October 11, 2023 Initiated: August 10, 2023 #Z-0004-2024

Product Description

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

Reason for Recall

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

Details

Recalling Firm
ARROW INTERNATIONAL Inc.
Units Affected
172 units
Distribution
US
Location
Morrisville, NC

Frequently Asked Questions

What product was recalled?
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. Recalled by ARROW INTERNATIONAL Inc.. Units affected: 172 units.
Why was this product recalled?
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 11, 2023. Severity: Critical. Recall number: Z-0004-2024.