Portex Tracheal Tube, Oral/Nasal, Siliconized, 3.5 mm Product Code: 100/111/035. Intended for oral and/or nasal intubati

FDA device recall Z-2061-2009 · posted 2009-09-18 · Terminated

Recall details

Recalling firm

Smiths Medical

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

BTR

Quantity affected

64,909 (US) 657,610 (International)

Distribution

Worldwide Distribution -- United States, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Borneo, Brazil, Brunei, Bulgaria, Canada, Chile, China, C¿¿te

Date initiated

2009-08-25

Date posted

2009-09-18

Date terminated

2012-11-16

Location

Hythe Kent, United Kingdom