Smiths Medical Hythe Hythe, Kent United Kingdom Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 2.5 mm Product Code: 100/126/025. Intended for oral and/or nasal intubation for airway management. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 2.5 mm Product Code: 100/126/025. Intended for oral and/or nasal intubation for airway management.
Brand
Smiths Medical Hythe Hythe, Kent United Kingdom
Lot Codes / Batch Numbers
Product manufactured before September 2009 and within its expiration date.
Products Sold
Product manufactured before September 2009 and within its expiration date.
Smiths Medical Hythe Hythe, Kent United Kingdom is recalling Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 2.5 mm Product Code: 100/126/025. Intended due to Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026