Recall Z-0654-2018— Arrow International Inc

Name: FDA recall Z-0654-2018
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: Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; 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

Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; 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.