FDA recall Z-2590-2023

ARROW INTERNATIONAL Inc. · Class II · device

Product

Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular

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 Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-08-10
Report date
2023-09-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2590-2023