FDA-Device2015-09-16Class II
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.
Elcam Medical, Inc.
Hazard
Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
Sold states
Texas, New Mexico and Pennsylvania
Affected count
7,721,580 units
Manufactured in
2 University Plz Ste 620, N/A, Hackensack, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2748-2015Don't want to check this manually?
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