—#115291

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

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K112033
Affected lot / code info: Product Code NSLG2C14, Lot # H44Y2P, Exp. Date 11-2013, Lot # J4AR58, Exp. Date 4-2017, Lot # J4AT3V, Exp. Date 4-2017, Lot # J4AW5A, Exp. Date 5-2017, Lot # J4AX7D, Exp. Date 5-2017, Lot # J4C34A, Exp. Date 6-2017, Lot # J4C448, Exp. Date 7-2017, Lot # J4C449, Exp. Date 7-2017, Lot # J4C85G, Exp. Date 7-2017, Lot # J4CF5Z, Exp. Date 9-2017 and Lot # J4CG31, Exp. Date 9-2017. Product Code NSLG2C25, Lot # H44Z6V, Exp. Date 11-2013, Lot # J4A16C, Exp. Date 12-2013, Lot # J4AT1P, Exp. Date 4-2017, Lot # J4AR5L, Exp. Date 4-2017, Lot # J4AU2K, Exp. Date 5-2017, Lot # J4AV17, Exp. Date 5-2017, Lot # J4AW75, Exp. Date 5-2017, Lot # J4AW76, Exp. Date 5-2017, Lot # J4AY0T, Exp. Date 5-2017, Lot # J4C09P, Exp. Date 6-2017, Lot # J4C30A, Exp. Date 6-2017, Lot # J4C34L, Exp. Date 6-2017, Lot # J4C44N, Exp. Date 7-2017, Lot # J4C928, Exp. Date 7-2017, Lot # J4C92C, Exp. Date 7-2017, Lot # J4C968, Exp. Date 8-2017, Lot # J4CA4P, Exp. Date 8-2017, Lot # J4CF0D, Exp. Date 8-2017, Lot # J4CH3W, Exp. Date 9-2017, Lot # J4CJ5Y, Exp. Date 9-2017, Lot # J4CJ99, Exp. Date 9-2017 and Lot # J4CK1H, Exp. Date 9-2017. Product Code NSLG2C35, Lot # H44V7N, Exp. Date 10-2013, Lot # H44V7M, Exp. Date 10-2013, Lot # H44V7P, Exp. Date 10-2013, Lot # H44X9M, Exp. Date 11-2013, Lot # H44X9L, Exp. Date 11-2013, Lot # H44X9R, Exp. Date 11-2013, Lot # H44Z3R, Exp. Date 11-2013, Lot # H44Z4C, Exp. Date 11-2013, Lot # H44Z54, Exp. Date 11-2013, Lot # J4A085, Exp. Date 12-2013, Lot # J4A134, Exp. Date 12-2013, Lot # J4AN7K, Exp. Date 4-2017, Lot # J4AN8E, Exp. Date 4-2017, Lot # J4AN8D, Exp. Date 4-2017, Lot # J4AP7W, Exp. Date 4-2017, Lot # J4AR5P, Exp. Date 4-2017, Lot # J4AT05, Exp. Date 4-2017, Lot # J4AT9G, Exp. Date 4-2017, Lot # J4AT9V, Exp. Date 4-2017, Lot # J4AU2Z, Exp. Date 5-2017, Lot # J4AV2R, Exp. Date 5-2017, Lot # J4AV2V, Exp. Date 5-2017, Lot # J4AV4P, Exp. Date 5-2017, Lot # J4AV4Z, Exp. Date 5-2017, Lot # J4AW3F, Exp. Date 5-2017, Lot # J4AW3N, Exp. Date 5-2017, Lot # J4AW8P, Exp. Date 5-2017, Lot # J4AW8Y, Exp. Date 5-2017, Lot # J4AX37, Exp. Date 5-2017, Lot # J4AX5Z, Exp. Date 5-2017, Lot # J4AX6E, Exp. Date 5-2017, Lot # J4AX8T, Exp. Date 5-2017, Lot # J4AX8U, Exp. Date 5-2017, Lot # J4AZ3P, Exp. Date 6-2017, Lot # J4AZ3V, Exp. Date 6-2017, Lot # J4AZ4W, Exp. Date 6-2017, Lot # J4AZ51, Exp. Date 6-2017, Lot # J4C11M, Exp. Date 6-2017, Lot # J4C11H, Exp. Date 6-2017, Lot # J4C15E, Exp. Date 6-2017, Lot # J4C17G, Exp. Date 6-2017, Lot # J4C174, Exp. Date 6-2017, Lot #, J4C187, Exp. Date 6-2017, Lot # J4C197, Exp. Date 6-2017, Lot # J4C17Y, Exp. Date 6-2017, Lot # J4C19M, Exp. Date 6-2017, Lot #, J4C225, Exp. Date 6-2017, Lot # J4C22H, Exp. Date 6-2017, Lot # J4C358, Exp. Date 6-2017, Lot # J4C35C, Exp. Date 6-2017, Lot # J4C36T, Exp. Date 6-2017, Lot # J4C427, Exp. Date 7-2017, Lot # J4C42D, Exp. Date 7-2017, Lot # J4C44P, Exp. Date 7-2017, Lot # J4C51U, Exp. Date 7-2017, Lot # J4C51W, Exp. Date 7-2017, Lot # J4C56E, Exp. Date 7-2017, Lot # J4C56A, Exp. Date 7-2017, Lot # J4C56Z, Exp. Date 7-2017, Lot # J4C56P, Exp. Date 7-2017, Lot # J4C58J, Exp. Date 7-2017, Lot # J4C58V, Exp. Date 7-2017, Lot # J4C65M, Exp. Date 7-2017, Lot # J4C66A, Exp. Date 7-2017, Lot # J4C66L, Exp. Date 7-2017, Lot # J4C758, Exp. Date 7-2017, Lot # J4C768, Exp. Date 7-2017, Lot # J4C85H, Exp. Date 7-2017, Lot # J4C85W, Exp. Date 7-2017, Lot # J4C906, Exp. Date 7-2017, Lot # J4C96P, Exp. Date 8-2017, Lot # J4C96Z, Exp. Date 8-2017, Lot # J4C879, Exp. Date 7-2017, Lot # J4CA4X, Exp. Date 8-2017, Lot # J4CA4Y, Exp. Date 8-2017, Lot # J4CC01, Exp. Date 8-2017, Lot # J4CC2G, Exp. Date 8-2017, Lot # J4CC4J, Exp. Date 8-2017, Lot # J4CD0C, Exp. Date 8-2017, Lot # J4CE10, Exp. Date 8-2017, Lot # J4CE16, Exp. Date 8-2017, Lot # J4CF0J, Exp. Date 8-2017, Lot # J4CF66, Exp. Date 9-2017, Lot # J4CJ0L, Exp. Date 9-2017, Lot # J4CJ5Z, Exp. Date 9-2017, Lot # J4CJ6J, Exp. Date 9-2017 and Lot # J4CK1K, Exp. Date 9-2017. Product Code NSLG2C45, Lot # H44W26, Exp. Date 10-2013, Lot # H44W25, Exp. Date 10-2013, Lot # H44W27, Exp. Date 10-2013, Lot # J4A19D, Exp. Date 12-2013, Lot # J4AR6G, Exp. Date 4-2017, Lot # J4AU2R, Exp. Date 5-2017, Lot # J4AV5U, Exp. Date 5-2017, Lot # J4AZ53, Exp. Date 6-2017, Lot # J4C042, Exp. Date 6-2017, Lot # J4C122, Exp. Date 6-2017, Lot # J4C18F, Exp. Date 6-2017, Lot # J4C23J, Exp. Date 6-2017, Lot # J4C270, Exp. Date 6-2017, Lot # J4C32F, Exp. Date 6-2017, Lot # J4C62J, Exp. Date 7-2017, Lot # J4C62P, Exp. Date 7-2017, Lot # J4C816, Exp. Date 7-2017, Lot # J4C90E, Exp. Date 7-2017, Lot # J4C90F, Exp. Date 7-2017, Lot # J4C99K, Exp. Date 8-2017, Lot # J4CA8M, Exp. Date 8-2017, Lot # J4CD6Z, Exp. Date 8-2017, Lot # J4CJ73, Exp. Date 9-2017 and Lot # J4CK5E, Exp. Date 9-2017. Product Code NSLG2S14, Lot # H44Z5R, Exp. Date 11-2013, Lot # J4C312, Exp. Date 6-2017, Lot # J4C639, Exp. Date 7-2017 and Lot # J4CG7Z, Exp. Date 9-2017. Product Code NSLG2S25, Lot # H44Z57, Exp. Date 11-2013, Lot # J4AU2W, Exp. Date 5-2017, Lot # J4AW4P, Exp. Date 5-2017, Lot # J4AW4N, Exp. Date 5-2017, Lot # J4AX4W, Exp. Date 5-2017, Lot # J4AZ5M, Exp. Date 6-2017, Lot # J4C09V, Exp. Date 6-2017, Lot # J4C18R, Exp. Date 6-2017, Lot # J4C22J, Exp. Date 6-2017, Lot # J4C27C, Exp. Date 6-2017, Lot # J4C34E, Exp. Date 6-2017, Lot # J4C34F, Exp. Date 6-2017, Lot # J4C34K, Exp. Date 6-2017, Lot # J4C37R, Exp. Date 6-2017, Lot # J4C49E, Exp. Date 7-2017, Lot # J4C49G, Exp. Date 7-2017, Lot # J4C576, Exp. Date 7-2017, Lot # J4C577, Exp. Date 7-2017, Lot # J4C63W, Exp. Date 7-2017, Lot # J4C67U, Exp. Date 7-2017, Lot # J4C75N, Exp. Date 7-2017, Lot # J4C75X, Exp. Date 7-2017 and Lot # J4C92G, Exp. Date 7-2017. Product Code NSLG2S35, Lot # H44Y6N, Exp. Date 11-2013, Lot # H44Y8A, Exp. Date 11-2013, Lot # H44Y8K, Exp. Date 11-2013, Lot # H44Z65, Exp. Date 11-2013, Lot # H44Z6J, Exp. Date 11-2013, Lot # J4A164, Exp. Date 12-2013, Lot # J4AR9C, Exp. Date 4-2017, Lot # J4AT1U, Exp. Date 4-2017, Lot # J4AT22, Exp. Date 4-2017, Lot # J4AT4H, Exp. Date 4-2017, Lot # J4AU2X, Exp. Date 5-2017, Lot # J4AW31, Exp. Date 5-2017, Lot # J4AW36, Exp. Date 5-2017, Lot # J4AW9D, Exp. Date, 5-2017, Lot # J4AW9H, Exp. Date, 5-2017, Lot # J4AX62, Exp. Date, 5-2017, Lot # J4AX8Y, Exp. Date, 5-2017, Lot # J4AX9F, Exp. Date, 5-2017, Lot # J4C100, Exp. Date, 6-2017, Lot # J4C109, Exp. Date, 6-2017, Lot # J4C15H, Exp. Date, 6-2017, Lot # J4C18W, Exp. Date, 6-2017, Lot # J4C209, Exp. Date, 6-2017, Lot # J4C20A, Exp. Date, 6-2017, Lot # J4C23K, Exp. Date, 6-2017, Lot # J4C27E, Exp. Date, 6-2017, Lot # J4C27H, Exp. Date, 6-2017, Lot # J4C32G, Exp. Date, 6-2017, Lot # J4C34M, Exp. Date, 6-2017, Lot # J4C435, Exp. Date, 7-2017, Lot # J4C43J, Exp. Date, 7-2017, Lot # J4C537, Exp. Date, 7-2017, Lot # J4C53G Exp. Date, 7-2017, Lot # J4C53T, Exp. Date, 7-2017, Lot # J4C57N, Exp. Date, 7-2017, Lot # J4C57P, Exp. Date, 7-2017, Lot # J4C64N, Exp. Date, 7-2017, Lot # J4C64U, Exp. Date, 7-2017, Lot # J4C73T, Exp. Date, 7-2017, Lot # J4C73X, Exp. Date, 7-2017, Lot # J4C914, Exp. Date, 7-2017, Lot # J4C90W, Exp. Date, 7-2017, Lot # J4C92Z, Exp. Date, 7-2017, Lot # J4CE93, Exp. Date, 8-2017 and Lot # J4CC02, Exp. Date, 8-2017. Product Code NSLG2S45, Lot # J4A12R, Exp. Date 12-2013, Lot # J4AV6G, Exp. Date 5-2017, Lot # J4AV6T, Exp. Date 5-2017, Lot # J4AX9V, Exp. Date 5-2017, Lot # J4C15V, Exp. Date 6-2017, Lot # J4C30V, Exp. Date 6-2017, Lot # J4C37T, Exp. Date 6-2017, Lot # J4C67E, Exp. Date 7-2017, Lot # J4C67J, Exp. Date 7-2017, Lot # J4C67M, Exp. Date 7-2017, Lot # J4C74T, Exp. Date 7-2017 and Lot # J4CC9G, Exp. Date 8-2017.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Ethicon Endo-Surgery Inc
Address: 4545 Creek Rd, Cincinnati, Ohio 45242-2803

Distribution

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.

Timeline

Recall initiated: 2012-11-06
Posted by FDA: 2013-01-31
Terminated: 2014-04-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115291. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.