U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Pediatric trachel tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.
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Smiths Medical issued an "Urgent Field Safety Notice" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm.
For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.