Recall Z-3199-2018— Arrow International Inc

Name: FDA recall Z-3199-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-17

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2018-07-17, terminated 2020-12-02. It names one FDA 510(k) clearance: K153487. Product: 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2. Reason: The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2018-07-17
Terminated: 2020-12-02
Firm location: Reading, PA, 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

4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2

Reason for recall

The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.

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