Recall Z-0758-2013— Ethicon Endo-Surgery Inc
Class II · Terminated
Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2012-11-06, terminated 2014-04-11. It names one FDA 510(k) clearance: K112033. 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. Reason: Potential for self activation while the device is in use, which may result in unintended thermal damage..
- Recalling firm
- Ethicon Endo-Surgery Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-06
- Terminated
- 2014-04-11
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.