Recall Z-2225-2016— WalkMed Infusion, LLC

Name: FDA recall Z-2225-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-14

Class II · Terminated

Class II FDA medical device recall by WalkMed Infusion, LLC, initiated 2016-06-14, terminated 2016-12-01. It names one FDA 510(k) clearance: K073444. Product: T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.. Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets..

Recalling firm: WalkMed Infusion, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-06-14
Terminated: 2016-12-01
Firm location: Englewood, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K073444 — TRITON MEIDCAL TMED IV-SETTriton Medical, LLC·cleared 2008-08-18

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

T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Reason for recall

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

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