FDA recall Z-0001-2024

ARROW INTERNATIONAL Inc. · Class I · 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

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.

Distribution

US

Key facts

Status
Ongoing
Initiation date
2023-08-10
Report date
2023-10-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2024