Z-2071-2009

Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.0 mm

Name: Z-2071-2009 Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.0 mm
Creator: Smiths Medical
Published: 2009-08-25
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-08-25 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical began a recall of Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.0 mm Product Code: 100/134/030. Intended for oral and/or nasal intubation for airway... on 2009-08-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2071-2009
Status: Terminated
Initiated: 2009-08-25
Posted: 2009-09-18
Terminated: 2012-11-16
Recalling firm: Abbott Medical
Product: Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.0 mm Product Code: 100/134/030. Intended for oral and/or nasal intubation for airway management.
Product code: BTR Tube, Tracheal (W/Wo Connector)
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 982 (US) 16,910 (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 d'Ivoire, Czech Republic, Denmark, East Timor, Egypt, Estonia, Finland, France, Georgia, Germany, Gibraltar, Greece, Guatemala, Vatican City, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Malaysia, Maldives, Malta, Mexico, New Zealand, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom and Uruguay.
Product codes and lots: Product manufactured before September 2009 and within its expiration date.

Product code BTR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)