Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Elcam Medical MANI 3G Plate BLS RAD B.BRAUN Recalled by Elcam Medical, Inc. Due to Punctured blister packages were detected during the packaging...

Date: July 19, 2015
Company: Elcam Medical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Elcam Medical, Inc. directly.

Affected 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

Quantity: 248,100

Why Was This Recalled?

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

Where Was This Sold?

Texas, New Mexico and Pennsylvania

About Elcam Medical, Inc.

Elcam Medical, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report