Medical device recalls Moderate risk

Halyard Health recalls KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Sys…

Recall date
January 16, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1221-2015
FDA classification
Class II
Brand / firm
Halyard Health
Sold / distributed
CA, FL, IL, LA, MA, MK, MN, MS, NM, NY, OK and TX and Japan.

Why it was recalled

Defect: A hole or crack was found which may cause air to leak.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.

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