FDA recall Z-2591-2023

Product

Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term 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 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-2591-2023