Physio-Control, Inc. recalls LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 9…
- Recall date
- August 30, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0230-2025
- FDA classification
- Class II
- Brand / firm
- Physio-Control, Inc.
- Sold / distributed
- U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A
Why it was recalled
Due to an out of tolerance tool being used on monitor/defibrillator systems.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.
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