Recall Z-2590-2023— ARROW INTERNATIONAL Inc.

Name: FDA recall Z-2590-2023
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: K073451. Product: Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular. 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

K073451 — PRESSURE INJECTABLE PICCArrow International, Inc.·cleared 2008-01-15

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 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.

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