NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
- Company
- Medtronic Xomed, Inc.
- Recall Initiated
- June 28, 2016
- Terminated
- August 7, 2019
- Recall Number
- Z-0901-2017
- Quantity
- 3752
- Firm Location
- Jacksonville, FL
Reason for Recall
Wire in tubing can become exposed, posing potential harm to the intubated patient.
Distribution
Worldwide Distribution - Nationwide Distribution including US Virgin Island and Puerto Rico , and to the countries of :Japan, Korea, China, Canada, Dominican Republic, Colombia, Chile, Costa Rica, Bahamas, Peru, Panama, Mexico, Argentina, Ecuador, Brazil, Trinidad and Tobago, Hong Kong, Taiwan, United Kingdom, Netherlands, Sri Lanka, Austria, Italy, Germany, United Arab Emirates, Saudi Arabia, Kuwait, France, Belgium, Oman, Ireland, Azerbaijan, India, Spain, Portugal, Luxembourg, Switzerland, Russian Federation, Austria, Greece, Cyprus, Portugal, India, Algeria, Iceland, Iran, Denmark, Hungary, Czech Republic, Ukraine, Turkey, Croatia, Israel, Norway, Oman, Sweden, Libya, Finland, Spain, Portugal, Algeria, Morocco, Poland, Canada, Malaysia, Singapore, Australia, and New Zealand
Lot / Code Info
All lots distributed since May 2012. Catalog Ref No. (reinforced standard tubes) 82-29306, 82-29307, & 82-29308; Catalog Ref No. (reinforced standard tubes, Japan) 8229306J, 8229307J, & 8229308J; Catalot Ref No. (reinforced contact tubes) 8229506, 8229507, & 8229508;
Root Cause
Use error
Action Taken
Medtronic sent an Urgent Product Safety Advisory letter dated June 28, 2016, to all affected customers informing them of the correction and providing instruction to avoid causing injury when using the EMG Endotracheal Tube. Recommended Actions included: inspecting the product thoroughly before use, testing the cuff by inflating it then deflating it before intubation, using a non-malleable stylet that closely matches the natural curve of the tube, not bending and flexing the tube excessively before use, and lubricating the cuff with a non-paralyzing, aqueous lubricant and a lubricated stylet. If customers found an EMG tube that appeared to have an electrode wire protruding from the distal end, the tube is not to be used and practitioners are urged to call Medtronic Product Quality Experience Department at 1-866-849-4003. For further questions , please call (904) 296-9600.