BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as eit
FDA device recall Z-0802-2012 · posted 2012-01-26 · Terminated
Recall details
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Reason for recall
- During manufacture, circuit traces were reversed which causes inaccurate display of information.
- Action taken
- 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.
- Root cause
- Finished device change control
- Status
- Terminated
- Product code
- GXY
- Quantity affected
- 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.
- Date initiated
- 2011-11-08
- Date posted
- 2012-01-26
- Date terminated
- 2013-03-13
- Location
- Boulder, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIS BILATERAL SENSOR (K062692) | Aspect Medical Systems, Inc. | 2006-12-13 |