Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308 [All products are packaged one unit per box.]
FDA Recall Z-0310-05 · Posted 2004-12-15
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Recalling FirmMedtronic Xomed, Inc.
Recall StatusTerminated
Product CodeETN
Date Initiated2004-10-29
Date Terminated2012-07-07
Product Quantity22569 EMG Tubes
Reason for Recall
The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound.
Root Cause
Other
Distribution Pattern
Distributed nationwide and worldwide. to countries in the five continents with the highest populations.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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