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
Reported: February 6, 2013 Initiated: November 6, 2012 #Z-0758-2013
Product Description
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
Reason for Recall
Potential for self activation while the device is in use, which may result in unintended thermal damage.
Details
- Recalling Firm
- Ethicon Endo-Surgery Inc
- Units Affected
- 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, 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.
- Location
- Cincinnati, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ethicon Endo-Surgery Inc. Units affected: 58,338 Instruments.
Why was this product recalled? ▼
Potential for self activation while the device is in use, which may result in unintended thermal damage.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 6, 2013. Severity: Moderate. Recall number: Z-0758-2013.
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