Recall Z-0758-2013 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Ethicon Endo-Surgery Inc
Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545
| Date | Jan 31, 2013 (initiated Nov 6, 2012) |
| Status | Terminated |
| Reason | Potential for self activation while the device is in use, which may result in unintended thermal damage. |
| Root cause | Process control |
| Action | Ethicon Endo-Surgery Inc. sent a "URGENT MEDICAL DEVICE RECALL" letter dated November 28, 2012, to all affected customers. The letter identified the the product the problem and the action needed to be taken by the customer. The customers were instructed to: 1. Examine your inventory immediately to determine if you have affected product on hand and remove the affected product(s). 2. Complete the Business Reply Form and fax it to Stericycle at 1-877-787-0367 within 3 business days, even if you do not have affected product. Please reference Event 3436. If you have product to be returned, ke |
| Quantity | 58,338 Instruments |
| Distribution | Worldwide Distribution - USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, & WV. and the countries Arab Emirates, Australia, Belgium, Canada, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112033 | ENSEAL G2 TISSUS SEALERS Ethicon Endo-Sugery, LLC, Nov 8, 2011 |