FDA-Device2020-05-13Class II
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Intuitive Surgical, Inc.
Hazard
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
Sold states
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
Affected count
1818 pouches
Manufactured in
1266 Kifer Rd Bldg 101, N/A, Sunnyvale, CA, United States
Products
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1906-2020Don't want to check this manually?
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