According to the FDA, Teleflex Inc has issued a worldwide recall of certain lots of Hudson RCI Sheridan Endotracheal Tubes. The recalled products are designed for oral or nasal intubation and are indicated for airway management.
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_Letter
The products involved in this recall are as follows:
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT), according to the FDA.
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 reports.
The FDA has classified the recall of Hudson RCI Sheridan Endotracheal Tubes as a Class I recall. According to an agency alert, 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_Letter
Consumers with questions may contact the company at 1-866-396-2111; 8am to 7pm, ET, Monday through Friday or email [email protected]
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm, or via Regular Mail or Fax (download formwww.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178).