Recall Z-0231-2019 ยท PUI Drape, Surgical, Exempt
Ecolab Inc
Instrument 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
| Date | Sep 14, 2018 |
| Status | Terminated |
| 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 |
| Quantity | 344 cases (6,880 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, Aus |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.