Devices

Device Recall Insulet OmniPod

  • Model / Serial
    Lot Numbers: L40771, L40892, L40901, L40905, L40997, L41199, L41208  Expanded Recall: Lot Codes: L41908, L41910, F41935
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and country of: Switzerland.
  • Product Description
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
  • Manufacturer
    Insulet Corporation
  • 1 Event

Manufacturer

Insulet Corporation
  • Manufacturer Address
    Insulet Corporation, 600 Technology Park Dr Ste 200, Billerica MA 01821-4126
  • Manufacturer Parent Company (2017)
    Insulet Corporation
  • Source
    USFDA

One device with a similar name

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Device Recall Insulet OmniPod
  • Model / Serial
    Lot Numbers: L40806, L40811, L40895, L40976, L41014, L41025, L41067, L41162, L41171, L41197, L41198, L41250  Expanded Recall: Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and country of: Switzerland.
  • Product Description
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
  • Manufacturer
    Insulet Corporation