Reported Apr 15, 2015 · Terminated
da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a…
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 100 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
- Lot codes and dates
Product number 400015-03da Vinci (Standard System) Inst. Arm Drape20 Pack
- Lot Numbers for Cloudy/Waxy issueALL
- lot numbers Lot Numbers for Tear issueNone
- Amount recalled
- 442,475 total all drape models
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
Why it was recalled
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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