Recall Z-0001-2024— ARROW INTERNATIONAL Inc.

Name: FDA recall Z-0001-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-10

Class I · Ongoing

Class I FDA medical device recall by ARROW INTERNATIONAL Inc., initiated 2023-08-10. It names one FDA 510(k) clearance: K153487. 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: 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 I
Status: Ongoing
Initiated: 2023-08-10
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K153487 — CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.)·cleared 2016-02-04

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 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.

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