Events

Recall of Device Recall BIS BILATERAL SENSOR

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nellcor Puritan Bennett Inc. (dba Covidien LP).

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
    60372
  • Event Risk Class
    Class 1
  • Event Number
    Z-0802-2012
  • Event Initiated Date
    2011-11-08
  • Event Date Posted
    2012-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105262
  • 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
    Electrode, cutaneous - Product Code GXY
  • Reason
    During manufacture, circuit traces were reversed which causes inaccurate display of information.
  • Action
    Covidien sent an Urgent Medical Device Recall letter dated November 8, 2011, to all affected customers. The letter identified the product, problem, and actions to be taken. Customers were instructed to segregate and return any product with the affected lot numbers according to the directions provided. If product was further distributed, the recall was to be continued to those customers. Further information is available at 800-635-5267.

Device

Device Recall BIS BILATERAL SENSOR
  • Model / Serial
    Lot numbers: 0528111A, 0603111A, 0604111A, 0606111A, 0607111A, 0608111A, 0609111A, 0615111A, 0620111A, 0621111A, 0624111A, 0625111A, 0627111A, 0701111A, 0707111A, 0712111A, 0713111A, 0725111A, 0726111A, 0726111B, 0727111A, 0727111B, 0728111A, 0728111B, 0729111A, 0729111B, 0801111A, 0808111A, 0809111A, 0810111A, 0811111A, 0812111A, 0813111A, 0814111A, 0820111A, 0821111A, 0822111A, 0822111B, 0823111A, 0823111B, 0824111A, 0824111B, 0825111A, 0825111B, 0826111A, 0826111B, 0921111A, 0923111A, 0923111B, 0924111A, 0926111A, 0927111A, 0930111A, 1001111A, 1003111A, 1004111A, 1005111A, 1006111A.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) including the states of: AZ, CA, CO, FL, GA, IL, KY, KS, LA, MA, MO, MS, NC, NM, NY, OH, PA, SD, TN, TX, UT, VA, WA, WI, WV and WY.
  • Product Description
    BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. || Product Usage: || To enable recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patients forehead. BIS technology is used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended.
  • Manufacturer
    Nellcor Puritan Bennett Inc. (dba Covidien LP)

Manufacturer

Nellcor Puritan Bennett Inc. (dba Covidien LP)
  • Manufacturer Address
    Nellcor Puritan Bennett Inc. (dba Covidien LP), 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA