Reported Oct 31, 2018 · Terminated
Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively…
Ecolab 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: Ecolab Inc · 1 Ecolab Pl · Saint Paul, MN · 55102-2739
Is this the product you have?
- Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed
- by Intuitive Surgical Product UsageMicrotek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]
- Lot codes and dates
Item 420291-03 Lot # D173147D173177D173517D173437D173487D172937D173407D173417D173317D180117D180177D173477D180087D173187D173137D172987D173217D173067D173497D173447D173427D173287D180167D180027D173577D173077D180097D180157D173627D173607D173467D173567D180197D173257D173637D173457D180267D180257D172997D173547D180317D180237D173227D173537D173507D180107D173617D173267D180247D173197D180057D180187D180347D180337D180377D180037D180307D180437D173017and D180507
- Amount recalled
- 9,364 cases (46,820 eaches)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.
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.
Free recall alerts
Get alerted about new Ecolab Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.