Medical device recalls Moderate risk

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

Recall date
June 28, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0901-2017
FDA classification
Class II
Brand / firm
Medtronic Xomed, Inc.
Sold / distributed
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, Uni…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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