Recall Z-2336-2018— Arrow International Inc

Name: FDA recall Z-2336-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-11

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2018-05-11, terminated 2020-04-20. It names one FDA 510(k) clearance: K862056. Product: Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins.. Reason: The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical intervention by exchanging the catheter for another CVC catheter..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2018-05-11
Terminated: 2020-04-20
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K862056 — [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIPArrow Intl., Inc.·cleared 1986-08-25

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

Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins.

Reason for recall

The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical intervention by exchanging the catheter for another CVC catheter.

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