Ethicon Endo-Surgery Inc recalls Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection

Recalled February 6, 2013 · FDA recall Z-0758-2013 · Ethicon Endo-Surgery

Hazard

Potential for self activation while the device is in use, which may result in unintended thermal damage. · FDA Class II

Units

58,338 Instruments

Sold at

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, Chile, China, Colombia, Cyprus, Hong Kong, Indonesia, Israel, India, South Korea, Kuwait, Malaysia, Panama, Philippines, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, Thailand, Turkey & Vietnam.

Description

Potential for self activation while the device is in use, which may result in unintended thermal damage.

Product

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

Manufacturer(s)

Ethicon Endo-Surgery Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →