Recall Z-2591-2023— ARROW INTERNATIONAL Inc.

Name: FDA recall Z-2591-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-10

Class II · Ongoing

Class II FDA medical device recall by ARROW INTERNATIONAL Inc., initiated 2023-08-10. It names one FDA 510(k) clearance: K121941. 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: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits..

Recalling firm: ARROW INTERNATIONAL Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-08-10
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K121941 — ARROW PICC POWERED BY ARROW VPS STYLETArrow International (Subsidiary of Teleflex Inc.)·cleared 2012-09-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.