Z-0703-2020Class II

HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 -

Name: Z-0703-2020 HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 -
Creator: Teleflex Medical
Published: 2019-10-30
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2019-10-30 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery... on 2019-10-30. FDA classified it as Class II and gives the reason as "The tracheal and brochial swivel connectors are incorrectly labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0703-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-30
Posted: 2019-12-18
Terminated: 2021-09-30
Recalling firm: Teleflex Medical
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.
Product code: CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Reason for recall: The tracheal and brochial swivel connectors are incorrectly labeled.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 53 units
Distribution: US Nationwide distribution in the states of CT, OK, LA, IL, GA, NY, CA, MT, MI, MA, FL.
Product codes and lots: Catalog: 5-16135; Manufacturing Lot: 73G1600257

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0703-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0703-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-18

Product code CBI

K851856Class IITracheal/bronchial Differential Ventilation TubeSheridan Catheter Corp. / cleared 1985-05-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)