Events

Rappel de Device Recall The ENSEAL G2 Tissue Sealers

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ethicon Endo-Surgery Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    64055
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0758-2013
  • Date de mise en oeuvre de l'événement
    2012-11-06
  • Date de publication de l'événement
    2013-01-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115291
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Electrosurgical, cutting and coagulation accessories - Product Code GEI
  • Cause
    Potential for self activation while the device is in use, which may result in unintended thermal damage.
  • 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.

Device

Device Recall The ENSEAL G2 Tissue Sealers
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    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
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Adresse du fabricant
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA