Reported Apr 15, 2015 · Terminated
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are…
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 / Si Surgical System IS2000 / IS3000, Instrument 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 420015-03da Vinci S / Si Instrument Arm Drape20 Pack
- Lot Numbers for Cloudy/Waxy issueALL
- lot numbers Lot Numbers for Tear issue
418 of 418 codes
D142175D142535D142895D143255D150135AD150555DA142695ADA143465AD142175AD142535AD142895AD143255AD150145D150555ADA142725DA143515D142185D142545D142905D143285D150145AD150565DA142745DA150075D142185AD142545AD142905AD143285AD150155D150565ADA142745ADA150085D142195D142555D142915D143295D150155AD150575DA142755DA150085AD142195AD142555AD142915AD143295AD150165D150575ADA142755ADA150125D142205D142585D142935D143305D150165AD150625DA142765DA150125AD142205AD142585AD142935AD143305A
- 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.
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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