Recall Z-1494-2014— Arrow International Inc

Name: FDA recall Z-1494-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-24

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2014-03-24, terminated 2015-09-21. It names one FDA 510(k) clearance: K121941. Product: Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.. Reason: Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2014-03-24
Terminated: 2015-09-21
Firm location: Reading, PA, 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 Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.

Reason for recall

Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter.

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