Reported May 13, 2020 · Terminated
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
- Lot codes and dates
- Model Number430013-12
- UDI Number00886874113486
- Lot NumbersAll Lots
- Amount recalled
- 1818 pouches
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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