Events

Recall of Abbott

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    26046
  • Event Risk Class
    Class 2
  • Event Number
    Z-0794-03
  • Event Initiated Date
    2003-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-10-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27007
  • Notes / Alerts
    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.
  • Extra notes in the data
    Pump, Infusion - Product Code FRN
  • Reason
    Products contain software deficiencies which could allow over infusion thereby administering excess medication.
  • Action
    On 4/1/03, the firm issued letters via Federal Express Overnight Delivery to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

Device

Abbott
  • Model / Serial
    All serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product received nationwide distribution to approx. 120 direct consignees. The firm identified 3 Govt. accounts: (1) Nthrn VA Comm. Hospital, 601 S. Carlin Spg. Rd., Arlington VA 22204, (2) Veterans Admin Med Ctr., 4100 W. 3rd St., Dayton OH 45428, (3) GW University Hospital, 901 23rd St. NW # 5306N, Washington DC 20037. The recall was appropriately extended to the user level; i.e., the hospital/medical centers, physicians and nurses who received the recalled product. There is no known Canadian distribution.
  • Product Description
    Gemstar¿ Therapy Pain Management I. V. Infusion Pump, List #: 13150-04; 2.9 Software Version
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 755 Jarvis Drive, Morgan Hill CA 95037
  • Source
    USFDA