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Intuitive Surgical, Inc. recalls da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Recalled May 13, 2020 · FDA recall Z-1906-2020 · Intuitive Surgical
Hazard
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier. · FDA Class II
Units
1818 pouches
Sold at
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
Description
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
Product
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →