Home / Recalls / Intuitive Surgical, Inc. / Z-1906-2020

Z-1906-2020 Class II Terminated

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
May 13, 2020
Initiation Date
October 25, 2018
Termination Date
April 5, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1818 pouches

Product Description

da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch

Reason for Recall

The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.

Distribution Pattern

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

Code Information

Model Number: 430013-12 UDI Number: 00886874113486 Lot Numbers: All Lots

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