Ecolab Inc: 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 Usage: Microtek 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]

Recall number

Z-0234-2019

Recalling firm

Ecolab Inc

Product

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 Usage: Microtek 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]

Status

Terminated

Initiated

2018-09-14

Posted

not on file

Terminated

2021-02-12

Reason

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.

Root cause

Under Investigation by firm

Action

Intuitive sent a communication letter to all their consignees with the following instructions: Actions to be taken by the Customer/User Please take the following Actions: 1. Locate and return all drapes with the affected part numbers and lots to Intuitive Surgical. 2. Inform affected personnel when the correction has been completed. 3. Please log into the da Vinci Online Community Field Action resource to read or complete any requested actions related to this issue, at this link: https://www.davincisurgerycommunity.com/ 4. In the case where the da Vinci online resource cannot be used, complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form. 5. Please retain a copy of this letter and the acknowledgement form for your files. Actions to be taken by Intuitive Surgical 1. Intuitive Surgical representatives will be available by phone to answer any questions related to this Medical Device Correction. 2. Credit up to the nearest full box will be provided for the return of affected product. If you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: " North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com

Quantity

9,364 cases (46,820 eaches)

Distribution

Worldwide - US Nationwide Distribution in the states of AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, AND WY In the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Iceland, Ireland, Italy, Martinique, Netherlands, Norway, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom

Lot, serial or model codes

Item 420291-03 Lot # D173147, D173177, D173517, D173437, D173487, D172937, D173407, D173417, D173317, D180117, D180177, D173477, D180087, D173187, D173137, D172987, D173217, D173067, D173497, D173447, D173427, D173287, D180167, D180027, D173577, D173077, D180097, D180157, D173627, D173607, D173467, D173567, D180197, D173257, D173637, D173457, D180267, D180257, D172997, D173547, D180317, D180237, D173227, D173537, D173507, D180107, D173617, D173267, D180247, D173197, D180057, D180187, D180347, D180337, D180377, D180037, D180307, D180437, D173017,and D180507.

510(k) numbers

not on file

PMA numbers

not on file

Product code

PUI

Firm FEI

3014342658

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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