Elcam Medical, Inc. recalls Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous…
- Recall date
- July 19, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2748-2015
- FDA classification
- Class II
- Brand / firm
- Elcam Medical, Inc.
- Sold / distributed
- Texas, New Mexico and Pennsylvania
Why it was recalled
Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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