FDA recall Z-1906-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2018-10-25

Report date

2020-05-13

Termination date

2024-04-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1906-2020