Reported Apr 15, 2015 · Terminated
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 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, 3 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 420290-03da Vinci Si Disposable Accessory Kit3 ARM5 Pack
- Lot Numbers for Cloudy/Waxy issueALL
- lot numbers Lot Numbers for Tear issue
163 of 163 codes
D142175D142175AD142185D142185AD142235D142235AD142245D142245AD142255D142305D142305AD142315D142315AD142345D142375D142375AD142385D142385AD142395D142455D142465D142465AD142475D142475AD142485D142515D142515AD142525D142525AD142535D142535AD142605D142605AD142615D142615AD142625D142635D142655D142655AD142665D142665AD142725D142725AD142735D142735AD142745D142755D142755AD142795D142795AD142825D142825AD142835D142885D142885AD142885AD142895D142905D142945D142955
- 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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