Devices

Device Recall FreeStyle Connect

  • Model / Serial
    All lots, including: FC0010, FC0012, FC0013, FC0014, FC0015, FC0016, FC0017, FC0020, FC0019, FC0018, FC0021, FC0022, FC0023, FC0026, FC0024, FC0025, FC0027, FC0028, FC0029, FC0030, FC0031, FC0032, FC0033, FC0034, FC0036
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was released for distribution to 28 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Product Description
    FreeStyle Connect Point of Care Blood Glucose Monitoring System, including Control Solutions and Test Strips; || Part Number: 70672-01; || Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
  • Manufacturer
    Abbott Diabetes Care, Inc.
  • 1 Event

Manufacturer

Abbott Diabetes Care, Inc.
  • Manufacturer Address
    Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall FreeStyle Connect
  • Model / Serial
    Lot Numbers: 0522524, 0526329, 0526326, 0529324, 0532203, 0533607, 0533641, 0534362, 0534404, 0534421, 0601135, 0601165, 0601608, 0601661
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was released for distribution to 28 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Product Description
    FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502; || Part Number: CAT70676-01
  • Manufacturer
    Abbott Diabetes Care, Inc.