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U.S. Department of Health and Human Services

Class 2 Device Recall Instrument Arm Drape

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 Class 2 Device Recall Instrument Arm Drapesee related information
Date Initiated by FirmSeptember 14, 2018
Create DateOctober 24, 2018
Recall Status1 Terminated 3 on February 12, 2021
Recall NumberZ-0231-2019
Recall Event ID 81244
Product Classification Drape, surgical, exempt - Product Code PUI
ProductInstrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system Distribute 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]
Code Information Item 420015-03 Lots # D173357, D173337A, D180047A, D180207, D180057, D180127A, and D180277
Recalling Firm/
Manufacturer		 Ecolab Inc
1 Ecolab Pl
Saint Paul MN 55102-2739
For Additional Information ContactRoman Blahoski
651-250-4385
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionIntuitive 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 in Commerce344 cases (6,880 eaches)
DistributionWorldwide - 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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