Events

Retiro De Equipo (Recall) de Device Recall ReNew Reusable Grasper and Dissector Tips

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Microline Surgical, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    78754
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0507-2018
  • Fecha de inicio del evento
    2017-07-13
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160285
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. if a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.
  • Acción
    The firm, Microline Surgical, Inc., sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 13, 2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately determine if you are in possession of the product and stop use; quarantine all products both new un-opened Reusable Tips AND Reusable Tips that have been used or are in current use (regardless of whether you have observed the malfunction); If you are a distributor or further distributed this product, we require that you immediately remove affected products from inventory and stop sales and shipping; identify customers immediately and notify them of this product recall; and all customers/distributors complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form (even if you have never received any of these products or have none in stock) by E-MAILING A SCANNED COPY TO: ReusableTipRecall@microlinesurgical.com or Fax to: 978-522-8490, ATTN: Reusable Tip Recall, or MAIL TO: Microline Surgical, Inc, 50 Dunham Road, Suite 1500, Beverly, MA 01915, ATTN: Recall Department. Microline has discontinued manufacture of the affected ReNew Reusable Tips and has initiated a ship-hold and new orders-hold for these products. For more information, please email ReusableTipRecall@microlinesurgical.com or contact Director of RA & QA at 978-922-9810 or email: mleighton@microlinesurgical.com.

Device

Device Recall ReNew Reusable Grasper and Dissector Tips
  • Modelo / Serial
    All lots of product codes: 3201,3221,3231,3241,3251,3261,3271,3281,3291,3301,3311,3321,3331,3341, 3351,3361,3371,3381,3401,3411,3421,3431  UDI's for listed lots of product codes: 3201-UDI 00811099011644,  3221-UDI 00811099011651, 3231-UDI 00811099011668, 3241-UDI 00811099011675, 3251-UDI 00811099011682, 3261-UDI 00811099011699, 3271-UDI 00811099011705, 3281-UDI 00811099011712, 3291-UDI 00811099011729, 3301-UDI 00811099011859, 3311-UDI 00811099011736, 3321-UDI 00811099011743, 3331-UDI 00811099011767, 3341-UDI 00811099011774, 3351-UDI 00811099011781, 3371-UDI 00811099011804, 3381-UDI 00811099011811, 3401-UDI 00811099011828, 3411-UDI 00811099011835, 3421-UDI 00811099011842, 3431-UDI 00811099011644
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (Nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, El Salvador, Hong Kong, India, Indonesia, Malaysia, Mexico, Panama, Peru, Argentina, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay & Vietnam.
  • Descripción del producto
    The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
  • Manufacturer
    Microline Surgical, Inc.

Manufacturer

Microline Surgical, Inc.
  • Dirección del fabricante
    Microline Surgical, Inc., 800 Cummings Ctr Ste 166T, Beverly MA 01915-6171
  • Empresa matriz del fabricante (2017)
    HOYA Corp.
  • Source
    USFDA