Recall Z-2748-2015— Elcam Medical, Inc.

Name: FDA recall Z-2748-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-19

Class II · Terminated

Class II FDA medical device recall by Elcam Medical, Inc., initiated 2015-07-19, terminated 2017-09-18. It names one FDA 510(k) clearance: K122953. Product: Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.. Reason: Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination..

Recalling firm: Elcam Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-07-19
Terminated: 2017-09-18
Firm location: Hackensack, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K122953 — OMNIPOD INSULIN MANAGMENT SYSTEMInsulet Corporation·cleared 2012-12-07

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 Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.

Reason for recall

Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.

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