Teleflex Incorporated has announced 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. The products involved in this recall are as follows:
The U.S. Food and Drug Administration (FDA) has classified the recall of Hudson RCI® Sheridan® Endotracheal Tubes as a Class I recall. 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 here.
Consumers with questions may contact the company at 1-866-396-2111; 8am to 7pm, ET, Monday through Friday or email email@example.com.
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 form 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).