510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-0802-2012

BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System...

Medtronic, Inc. / initiated 2011-11-08 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Nellcor Puritan Bennett Inc. (dba Covidien LP) began a recall of 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... on . The reason FDA records is "During manufacture, circuit traces were reversed which causes inaccurate display of information". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0802-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic, Inc.
Product
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.
Product code
GXY Electrode, Cutaneous
Reason for recall
During manufacture, circuit traces were reversed which causes inaccurate display of information.
Root cause tag
manufacturing process
FDA root cause
Finished device change control
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.
Quantity in commerce
8510 units (851 boxes of 10)
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 codes and lots
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.