Class I Recall - Select Hudson RCI Sheridan Endotracheal Tubes by Teleflex Incorporated
Teleflex Incorporated has announced a worldwide recall of certain lots of Hudson RCI Sheridan Endotracheal Tubes. Product sizes 6.0, 6.5, 7.0, 7.5, 8.0 and 8.5 mm are included in this recall.
These recalled products were distributed from October 2016 to May 2019. Specific lot codes may be found through the following link: https://p.widencdn.net/ivsxip/AN_ETT_Connector_Customer_Recall_LetterExternal Link Disclaimer
This voluntary recall is due to reported complaints indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT).
The immediate consequence for patients is disconnection from the breathing circuit, which may result in insufficient oxygenation, requiring medical intervention. There have been four reports of death, and additional reports of serious injury where ETT disconnection may have been a factor.
The FDA defines a Class I recall as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Consumers who have affected product should immediately discontinue use and return all affected product to Teleflex or its distributor. The recall notice, with a list of affected product codes and lot numbers, can be found through the following link: https://p.widencdn.net/ivsxip/AN_ETT_Connector_Customer_Recall_LetterExternal Link Disclaimer
Consumers with questions may contact the company at 1-866-396-2111; 8am to 7pm, ET, Monday through Friday or email firstname.lastname@example.org.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form or submit by fax to 1-800-FDA-0178.
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