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 Recall Z-0703-2020 · Posted None
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeCBI
Date Initiated2019-10-30
Date Terminated2021-09-30
Product Quantity53 units
Reason for Recall
The tracheal and brochial swivel connectors are incorrectly labeled.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of CT, OK, LA, IL, GA, NY, CA, MT, MI, MA, FL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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