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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