Intuitive Surgical, Inc. recalls da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
- Recall date
- October 25, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1906-2020
- FDA classification
- Class II
- Brand / firm
- Intuitive Surgical, Inc.
- Sold / distributed
- Updated information provided on 03/18/2020: FL, OH, TN, NJ, PA, MD, NY, CA, MN, NV, OR, HI, VA, TX, AL, CA, IL, CN, and NC. OUS: APAC (Asia Pacific) - South Korea
Why it was recalled
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
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