Medtronic endotracheal tubes recalled due to manufacturing nonconformity
Medtronic Xomed is recalling over 301,000 NIM TRIVANTAGE EMG Endotracheal Tubes due to a manufacturing nonconformity. These devices were distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a manufacturing nonconformity in a critical airway medical device. The source describes a risk-of-harm product with no reported injuries or illnesses, meeting the criteria for High severity.
Plain-English summary
Medtronic Xomed, Inc. is recalling the NIM TRIVANTAGE EMG Endotracheal Tube. The recall covers over 301,926 devices distributed across multiple product numbers.
The recall is due to a manufacturing nonconformity that could lead to multiple issues with these devices. The FDA classified this as a Class II recall.
The affected devices were distributed worldwide, including throughout the United States and to numerous countries across North America, South America, Europe, Asia, Africa, Australia, and the Middle East.
The recalled product
- Product
- NIM TRIVANTAGE EMG Endotracheal Tube
- Manufacturer
- Medtronic Xomed, Inc.
- Hazard
- Affected units
- 301,926
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Products: 1) Product Number 8229705 (GTIN 00763000033934)
- Lots: 0218762694
- 0218663943
- 0219904500
- 0220293429
- 0220584798
- 0220756285
- 0220774358
- 0221736070
- 0221805033
- 0222186741
- 0222495993
- 0222591367 2) Product Number 8229706 (GTIN 00763000033941)
- Lots: 0218663944
- 0218664146
- 0218762695
- 0218762699
- 0218762698
- 0218762697
- 0219010138
Distribution
Distributed nationwide across the United States.
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