Medical device recalls Moderate risk

Sun Med, LLC recalls STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1

Recall date
May 24, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2145-2018
FDA classification
Class II
Brand / firm
Sun Med, LLC
Sold / distributed
IL & OH distributors

Why it was recalled

There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.

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

What was recalled

STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1

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