Events

Recall of Device Recall BodyGuard

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

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
    70294
  • Event Risk Class
    Class 2
  • Event Number
    Z-1126-2015
  • Event Initiated Date
    2015-01-16
  • Event Date Posted
    2015-02-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132890
  • 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
    Cme america is recalling the bodyguard and bodyguard 323 infusion pumps due to the potential for an over delivery.
  • Action
    CME America sent an "Urgent Medical Device Recall" letter dated January 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required Action for Users: To date there have been no reports of adverse events or serious injury. However, there is the potential for serious injury or death. CME America recommends that you DO NOT use the BodyGuard 323 pump for PCA infusion. If your devices are currently in use, be sure that the programmed parameters DO NOT involve a patient controlled bolus dose less than 0.1 miln volume (translated into meg or mg). Follow-up Actions by CME America: CME America has identified the root cause of this issue and is recommending installation of a new version of software, USA36B4, for affected BodyGuard 323 infusion pumps. This software is identical to the previously released version, USA36A4.2. However the designation of B4 in the software name will identify updated software in each device. CME America will contact all affected customers within 60 days to initiate the scheduling process for the remediation. Your assistance is appreciated and necessary to prevent use and facilitate remediation of the recalled product. CME America can address any questions regarding the recalled product by calling the CME America recall line at 720-839-2391.

Device

Device Recall BodyGuard
  • Model / Serial
    All product with USA36A4.4 version of software affected
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada.
  • Product Description
    BodyGuard 323 pump, models || 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, || 100-603XSA and 100-603XSAP
  • Manufacturer
    CME America, LLC

Manufacturer

CME America, LLC
  • Manufacturer Address
    CME America, LLC, 14998 W 6th Ave, Golden CO 80401-6587
  • Manufacturer Parent Company (2017)
    CME America, LLC
  • Source
    USFDA