Events

Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle

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 International Medsurg Connection, 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
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2839-2017
  • Fecha de inicio del evento
    2017-06-23
  • 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=157226
  • 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
    Syringe, piston - Product Code FMF
  • Causa
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.

Device

Device Recall Piston Syringe and Hypodermic Needle
  • Modelo / Serial
    Catalog No. SN0052015. Known Lot No. ("x" represents any release number): 12-6780-x, 12-6925-x, 12-6968-x, 12-7060-x, 12-7119-x, 12-7144-x, 12-7177-x, 12-7208-x, 12-7258-x, 12-7259-x, 12-7324-x, 12-7325-x, 12-7363-x, 12-7391-x, 12-7412-x, 12-7463-x, 12-7469-x, 12-7472-x, 12-7499-x, 13-6780-x, 13-7538-x, 13-7560-x, 13-7581-x, 13-7648-x, 13-7667-x, 13-7702-x, 13-7704-x, 13-7719-x, 13-7733-x, 13-7761-x, 13-7841-x, 13-7920-x, 13-7950-x, 13-7966-x, 13-7988-x, 13-8006-x, 13-8032-x, 13-8039-x, 13-8082-x, 13-8083-x, 13-8084-x, 13-8143-x, 13-8144-x, 13-8145-x, 13-8149-x, 13-8184-x, 13-8185-x, 13-8489-x, 13-8272-x, 14-8327-x, 14-8335-x, 14-8354-x, 14-8385-x, 14-8386-x, 14-8396-x, 14-8440-x, 14-8441-x, 14-8442-x, 14-8457-x, 14-8509-x, 14-8512-x, 14-8513-x, 14-8540-x, 14-8541-x, 14-8542-x, 14-8583-x, 14-8628-x, 14-8631-x, 14-8696-x, 14-8737-x, 14-8794-x, 14-8807-x, 14-8829-x, 14-8863-x, 14-9851-x, 14-9015-x, 14-9035-x, 14-9064-x, 14-9081-x, 15-0113-x, 15-9333-x, 15-9350-x, 15-9351-x, 15-9364-x, 15-9377-x, 15-9442-x, 15-9447-x, 15-9492-x, 15-9550-x, 15-9587-x, 15-9605-x, 15-9630-x, 15-9638-x, 15-9639-x, 15-9716-x, 15-9723-x, 15-9759-x, 15-9797-x, 15-9805-x, 15-9860-x, 15-9873-x, 15-9876-x, 15-9963-x, 16-0366-x, 16-0399-x, 16-0439-x, 16-0441-x, 16-0473-x, 16-0527-x, 16-0624-x, 16-0632-x, 16-0655-x, 16-0736-x, 16-0783-x, 16-0839-x, 16-0904-x, 16-0969-x, 16-1005-x, 16-1023-x, 16-1040-x, 16-1053-x, 16-1054-x, 16-1055-x, 16-1079-x, 16-1101-x, 16-1102-x, 16-1153-x, 16-1165-x, 17-1443-x, 17-1492-x, 17-1527-x, 17-1535-x, 17-1557-x, 17-1562-x, 17-1575-x, 17-1609-x, 17-1613-x, 17-1617-x, 17-1624-x, 17-1637-x, 17-1691-x, 17-1715-x, 17-1791-x.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
  • Descripción del producto
    Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.5, 100 per box, 15 boxes/case, 1,500/case || The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
  • Manufacturer
    International Medsurg Connection, Inc.

Manufacturer

International Medsurg Connection, Inc.
  • Dirección del fabricante
    International Medsurg Connection, Inc., 935 N Plum Grove Rd Ste F, Schaumburg IL 60173-4770
  • Empresa matriz del fabricante (2017)
    International Medsurg Connection Inc.
  • Source
    USFDA