Lifescan OneTouch SureStep Meter

  • Modelo / Serial
    The following are numbers (kit configurations) are affected by this recall: 010-341-18(OT SureStep system), 010-341-20 (OT SureStep System), 010-341-52 (OT SureStep starter kit), 010-411-06 (OT SureStepE Meter Warranty), 091-041-106 (OT SureStep Meter Warranty PBK).  The following lot numbers are affected: 42711002-01, 42711002-02, 42711002-03, 42731001-01, 42731001-02, 42891003-01, 42901001-01, 42901001-02, 42901001-03, 42911002-01, 42911002-02, 42911002-03, 42921002-01, 42921002-02, 42931001-01, 42931001-02, 42931001-03, 42941001-01, 42941001-02, 42941002-01, 42941002-02, 42941002-03, 42951001-01, 42951001-02, 42951001-03, 42951002-01, 42951002-02, 42951003-01, 42951003-02, 42961001-02, 42961004-01, 42971002-01, 42971002-02, 42971002-03, 42971002-04, 42971002-05, 42971004-01, 42981001-01, 42981001-02, 42981001-03, 42981001-04, 42981001-05, 42981001-06, 42991001-01, 42991001-02, 42991001-03, 43621003-01, 43631001-01, 50051004-01, 50051004-02, 50051004-03, 50061001-01, 50061001-02, 50061001-03, 50081002-01, 50081002-02, 50081002-03, 50091001-01, 50091002-02, 50101001-01, 50101001-02, 50111001-01, 50111002-01, 50121001-01, 50121001-02, 50131001-01, 50131001-02, 50141001-02, 50141001-03, 50171001-04, 50311003-03, 50311003-04, 50321002-01, 50331001-02, 50351002-01, 50351002-02, 50361005-01, 50371001-01, 50371001-02, 50471001-04, 50481001-03.  ***On 4/14/06 the recall was expanded to include meters with Serial Numbers Between L3152Rxxxxxx and L5348Rxxxxxx, 31532002-01 to 53411001-01, 888-845-8904***
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Total amount of product distributed in the U.S. is 19,177 units, to distribution centers to be distributed to retailers, Health Care Professionals, wholesalers, and mail order companies. The product was distributed throughout the United States; 29,377 were distributed to Asia, Europe and Latin America.
  • Descripción del producto
    Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035-6301
  • Source
    USFDA