Recall Z-0701-2017 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
3M Company - Health Care Business
3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) Product Usage: 3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal El
| Date | Dec 3, 2016 (initiated Oct 26, 2016) |
| Status | Terminated |
| Reason | 3M is recalling Universal Electrosurgical Pads because a report of an unintended material (process liner) in the product. This may prevent or impede the safe return of electrosurgical current following Electrosurgical Unit (ESU) activation. This defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body. |
| Root cause | Equipment maintenance |
| Action | 3M sent an Urgent Medical Device Recall letter dated October 26, 2016 to affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to complete and return the attached Customer Product Return and Recall Form. Customers with questions can contact 3M Health Care Customer Helpline at 1-800-228-3957, 8:30 am - 7:00 pm EST. |
| Quantity | 32,000 pads |
| Distribution | Worldwide Distribution - US Nationwide in the states of AR, AZ, CA, FL, GA, ID, IL, KY, NC, NY, TN, TX, VA and the countries of Canada, Chile, Costa Rica, Germany, Japan, Mexico and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974279 | 3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C) 3M Healthcare, Jan 30, 1998 |