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Z-0901-2017 Class II Terminated

Recalled by Medtronic Xomed, Inc. — Jacksonville, FL

FDA device recall Z-0901-2017 was initiated by Medtronic Xomed, Inc. on June 28, 2016 and is designated Class II. Reason for recall: Wire in tubing can become exposed, posing potential harm to the intubated patient. The recall status is terminated (terminated August 7, 2019). Affected quantity: 3752.

Recall Details

Product Type: Devices
Report Date: January 4, 2017
Initiation Date: June 28, 2016
Termination Date: August 7, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3752

Product Description

NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.

Reason for Recall

Wire in tubing can become exposed, posing potential harm to the intubated patient.

Distribution Pattern

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

Code Information

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;

Other recalls by Medtronic Xomed, Inc.

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Z-2409-2024 Class I — NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vi (June 24, 2024)
Z-0696-2024 Class II — NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 822970 (November 7, 2023)
Z-1223-2022 Class II — NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 (May 3, 2022)
Z-1224-2022 Class II — NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 (May 3, 2022)
Z-1520-2022 Class I — NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) RE (April 29, 2022)
Z-1519-2022 Class I — NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 (April 29, 2022)
Z-1521-2022 Class I — NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) (April 29, 2022)