—#177978

Product

HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The Sheridan Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.

FDA product code: CBI — Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K851856
Affected lot / code info: Catalog: 5-16135; Manufacturing Lot: 73G1600257

Why it was recalled

The tracheal and brochial swivel connectors are incorrectly labeled.

Root cause (FDA determination)

Process control

Action the firm took

An Urgent Medical Device Recall letter was sent to customers via FedEx 2-day service notifying consignees of the recall. Customers are asked to immediately discontinue use and quarantine any products with the affected product code and lot number identified in the letter. Consignees are asked to complete a Recall Acknowledgement Form and fax or email it to the recalling firm. Additional questions may be directed to Customer Service at 1-866-396-2111.

Recalling firm

Firm: Teleflex Medical
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: US Nationwide distribution in the states of CT, OK, LA, IL, GA, NY, CA, MT, MI, MA, FL.

Timeline

Recall initiated: 2019-10-30
Terminated: 2021-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177978. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.