ClearanceBrief
Recall Z-1246-2012 ยท LFL Instrument, Ultrasonic Surgical

Ethicon Endo-Surgery Inc

ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw, Model # NSLG2S14 and ENSEAL 5 mm Diameter Tissue Sealer G2 25 cm Length Straight Jaw, Model # NSLG2S25. Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969 The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electr

DateMar 21, 2012 (initiated Jan 26, 2012)
StatusTerminated
ReasonEthicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i) Continuous Activation: The ENSEAL device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) No Activation
Root causeNonconforming Material/Component
ActionEthicon Endo-Surgery sent an Urgent Medical Device Recall letter dated February 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop use of the affected product, fill out the attached Business Reply Form (BRF) and return to and return the affected product to: Ethicon Endo-Surgery ATT: ENSEAL G2 Recall 4545 Greek Road Cincinnati, Ohio 45242 Customers were instructed to choose one of the following response options: Return the Business Reply Form to their sales represen
Quantity84 pieces
DistributionWorldwide Distribution - USA including AZ, CA, CT, FL, IL, IN, KS, KY, MA, MI, MO, NC, NY, OH, PA, TN & TX and the countries of Arab Emirates, Austria, Belgium, France, Germany, Great Britain, Italy, Jordan, Kingdom of Saudi Arabia, Lebanon, Portugal, Slovenia, Sweden and Turkey.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K112033ENSEAL G2 TISSUS SEALERS
Ethicon Endo-Sugery, LLC, Nov 8, 2011