Home / Recalls / Ecolab Inc / Z-0232-2019

Z-0232-2019 Class II Terminated

Recalled by Ecolab Inc — Saint Paul, MN

FDA device recall Z-0232-2019 was initiated by Ecolab Inc on September 14, 2018 and is designated Class II. 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 recall status is terminated (terminated February 12, 2021). Affected quantity: 88 cases (1,760 eaches).

Recall Details

Product Type: Devices
Report Date: October 31, 2018
Initiation Date: September 14, 2018
Termination Date: February 12, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 88 cases (1,760 eaches)

Product Description

Camera 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 / 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]

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.

Distribution Pattern

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

Code Information

Item 420279-03 Lots # D180437A and D180567

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