Recall notice
Portex Intubation Endotracheal Tubes recalled due to Smaller Diameter of Device, USA
10 months ago •source fda.gov
United States
Smiths Medical has issued an Urgent Medical Device Correction to notify affected global customers of a potential issue with the 2.0, 2.5, 3.0 and 3.5 mm sizes of Intubation ORAL/NASAL Endotracheal Tube products being smaller than expected. To date, Smiths Medical has received eight (8) reports of serious injury that are potentially related to this issue. This product is recalled in the United States. Products were manufactured from 01 October 2019 to 03 October 2024 and distributed from 30 October 2019 to 16 December 2024.If the diameter of the device is smaller than expected, it may potentially result in inadequate ventilation to the patient, post-insertion of the endotracheal tube. In such situations, the patient may experience hypoxia, underdose, and/or cardiopulmonary collapse which may lead to death.
Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smiths-medical-issues-urgent-medical-device-correction-informing-customers-potential-issue-certain
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