FDA-Device2015-09-16Class II
Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
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
248,100
Manufactured in
2 University Plz Ste 620, N/A, Hackensack, NJ, United States
Products
Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2749-2015Don't want to check this manually?
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