Recall Z-1869-2017— Elcam Medical, Inc.

Name: FDA recall Z-1869-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-02

Class II · Terminated

Class II FDA medical device recall by Elcam Medical, Inc., initiated 2017-02-02, terminated 2018-06-08. It names one FDA 510(k) clearance: K060231. Product: Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.. Reason: The stopcock was found to have punctures..

Recalling firm: Elcam Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-02-02
Terminated: 2018-06-08
Firm location: Hackensack, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K060231 — CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCKElcam Medical Acal·cleared 2006-04-13

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

Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Reason for recall

The stopcock was found to have punctures.

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