Recall Z-0652-2018— Arrow International Inc

Name: FDA recall Z-0652-2018
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 2020-04-14. It names one FDA 510(k) clearance: K862056. Product: Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dates Feb 2018 - Nov 2018. Reason: These finished good kits may contain the incorrect Springwire Guide (SWG)..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-10-17
Terminated: 2020-04-14
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 Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dates Feb 2018 - Nov 2018

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

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