FDA Device Recall Z-1520-2022

Medtronic Xomed, Inc. · Jacksonville, FL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306

Lot / serial / GTIN: a) REF 8229308; UDI 00643169789548, 00763000745837, 00763000882402; ALL LOTS. b) REF 8229307; UDI 00643169789531, 00763000745820, 00763000882396; ALL LOTS. c) REF 8229306; UDI, 00643169789524, 00763000745813, 00763000882389; ALL LOTS.

Quantity: 1,133,612 units

Reason for recall

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

Recall record

Recall number: Z-1520-2022
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: 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
Recall initiated: 2022-04-29
Classified by FDA Center: 2022-09-01
FDA published: 2022-09-07
Recalling firm: Medtronic Xomed, Inc.
Firm location: Jacksonville, FL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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