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Terminated

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

FDA Recall Z-0758-2013 · Posted 2013-01-31

Recall StatusTerminated
Product CodeGEI
Date Initiated2012-11-06
Date Terminated2014-04-11
Product Quantity58,338 Instruments

Reason for Recall

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

Firm 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, keep a copy of this form for your records. 3.To return affected product, photocopy your completed Business Reply Form, place it in the box with your product, and affix the pre-printed UPS shipping label to return to Stericycle. Note: Returned product will be credited. Should you have any questions, please contact your local representative or call our Customer Support Center, 1-800-873-3636, Option 6.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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