da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Reported: May 13, 2020 Initiated: October 25, 2018 #Z-1906-2020
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.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 1818 pouches
- 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
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch. Recalled by Intuitive Surgical, Inc.. Units affected: 1818 pouches.
Why was this product recalled? ▼
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2020. Severity: Moderate. Recall number: Z-1906-2020.
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