Recall Z-0690-2018— Arrow International Inc

Name: FDA recall Z-0690-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-17

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-10-17, terminated 2020-04-21. It names one FDA 510(k) clearance: K121941. Product: ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet. Reason: The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-10-17
Terminated: 2020-04-21
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¿ PICC powered by ARROW¿ VPS¿ Stylet

Reason for recall

The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.

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