Santanello Surgical LLC recalls VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigatio…
- Recall date
- June 10, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2237-2019
- FDA classification
- Class II
- Brand / firm
- Santanello Surgical LLC
- Sold / distributed
- FL,OK, OH, NY, ME, MN, WI
Why it was recalled
Lack of package integrity may compromise sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
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