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.
- Company
- Teleflex Medical
- Recall Initiated
- October 30, 2019
- Terminated
- September 30, 2021
- Recall Number
- Z-0703-2020
- Quantity
- 53 units
- Firm Location
- Morrisville, NC
Reason for Recall
The tracheal and brochial swivel connectors are incorrectly labeled.
Distribution
US Nationwide distribution in the states of CT, OK, LA, IL, GA, NY, CA, MT, MI, MA, FL.
Lot / Code Info
Catalog: 5-16135; Manufacturing Lot: 73G1600257
Root Cause
Process control
Action Taken
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.
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