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Recall Observatory FDA recall evidence

Device product

NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506

Z-1519-2022

April 29, 2022

Class I

Product summary

Firm
Medtronic Xomed, Inc.
Event
Event 90711
Status
Ongoing
Classification
Class I
Quantity
81,555 units
Official record key
device-enforcement:Z-1519-2022

Official wording

Reason: The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.

Code information: a) REF 8229508; UDI 00643169789579, 00763000745868, 00763000882433; ALL LOTS. b) REF 8229507; UDI 00643169789562, 00763000745851, 00763000882426; ALL LOTS. c) REF 8229506; UDI 00643169789555, 00763000745844, 00763000882419; ALL LOTS.

Distribution pattern: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Korea, Republic Of, Kosovo, Kuwait, Libya, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, North Macedonia, Northern Mariana Islands, Norway, Oman, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.