Reported Apr 15, 2015 · Terminated
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to…
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 Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 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 420291-03da Vinci Si Disposable Accessory Kit4 ARM5 Pack
- Lot Numbers for Cloudy/Waxy issueALL
- lot numbers Lot Numbers for Tear issue
126 of 126 codes
D142185D142195D142195AD142205D142215D142255D142255AD142265D142265AD142325D142325AD142335D142335AD142345D142395D142405D142405AD142415D142415AD142445D142445AD142455D142455AD142535D142545D142545AD142555D142555AD142585D142585AD142595D142595AD142675D142675AD142685D142685AD142695D142695AD142745D142745AD142755D142765D142805D142805AD142815D142815AD142825D142865D142865D142865AD142875D142875AD142885D142915D142935D142935AD142945D142975D142975AD142985
- Amount recalled
- 442,475 total for 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.
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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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