Devices are being removed from use after certain sizes were found to have smaller diameters than expected, potentially limiting airflow. Eight injuries have been reported.

Smiths Medical is recalling oral/nasal endotracheal tubes after becoming aware that certain sizes of products may have a smaller diameter than expected, which may not provide enough ventilation to the patient.

This recall involves removing the affected devices from where they are used or sold. The use of the affected product may cause serious adverse health consequences, including lack of oxygen that may lead to organ failure, swelling of the larynx, cardiopulmonary arrest, and death. There have been eight reported injuries and no reports of death, according to a medical device recall notice from the US Food and Drug Administration (FDA).

Affected product:

Product NameProduct CodeUDI
TRACHEAL TUBE SILICONISED ORAL/NASAL UNCUFFED 2.5MM 10/BX100/111/02515019315018848
TRACHEAL TUBE M/EYE UNCUFFED SILICONISED ORAL/NASAL 3.5MM 10/BX100/141/03515019315019043
TRACHEAL TUBE MURPHY EYE UNCUFFED SILICONISED ORAL/NASAL 3.0MM 10/BX100/127/03015019315019814
TRACHEAL TUBE MURPHY EYE UNCUFFED SILICONISED ORAL/NASAL 3.0MM 10/BX100/141/03015019315019036
TRACHEAL TUBE IVORY UNCUFFED ORAL/NASAL 2.5MM 10/BX100/105/02515019315018633
TRACHEAL TUBE MURPHY EYE UNCUFFED SILICONISED ORAL/NASAL 2.5MM 10/BX100/127/02515019315019807
TRACHEAL TUBE SILICONIZED CUT-TOLENGTH. ORAL 2.5MM 10/BX100/126/02515019315056758
TRACHEAL TUBE MURPHY EYE UNCUFFED SILICONISED ORAL/NASAL 2.5MM 10/BX100/141/02515019315019029
TRACHEAL TUBE SILICONISED ORAL/NASAL UNCUFFED 2.0MM 10/BX100/111/02015019315018831
TRACHEAL TUBE SILICONISED ORAL/NASAL UNCUFFED 3.0MM 10/BX100/111/03015019315018855
TRACHEAL TUBE SILICONIZED CUT-TOLENGTH. ORAL 3.0MM 10/BX100/126/03015019315056765
TRACHEAL TUBE SILICONIZED CUT-TOLENGTH. ORAL 3.5MM 10/BX100/126/03515019315056772
TRACHEAL TUBE IVORY UNCUFFED ORAL/NASAL 3.5MM 10/BX100/105/03515019315018657
TRACHEAL TUBE MURPHY EYE UNCUFFED SILICONISED ORAL/NASAL 3.5MM 10/BX100/127/03515019315019821
TRACHEAL TUBE SILICONISED ORAL/NASAL UNCUFFED 3.5MM 10/BX100/111/03515019315018862
TRACHEAL TUBE IVORY UNCUFFED ORAL/NASAL 3.0MM 10/BX100/105/03015019315018640

For affected lots, see full list of affected devices.

What to Do

On Feb 13, Smiths Medical sent all affected customers an Urgent Medical Device Correction recommending the following actions: 

  • Check inventory and stop use of affected products. 
  • Destroy all affected products. If destruction is not possible, quarantine until the product can be disposed of. 
  • Share this notification with all potential device users of the device, including users at other locations. 
  • Complete and return the customer response form included with the letter to [email protected] within 10 days of receipt.
  • Distributors: If affected products were distributed, immediately forward this notice and request the recipients complete the response form and return it.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

ID 200330254 © Andrey Golubtsov | Dreamstime.com

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