Z-1078-2015Class II

Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical

Name: Z-1078-2015 Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical
Creator: Teleflex Medical
Published: 2015-01-09
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2015-01-09 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical on 2015-01-09. FDA classified it as Class II and gives the reason as "Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1078-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-09
Posted: 2015-02-10
Terminated: 2016-09-27
Recalling firm: Teleflex Medical
Product: Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Teleflex Medical sent an " Urgent Medical Device Recall Notification" dated January 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to immediately discontinue use and quarantine any of the affected products, return the product and to complete the enclosed Recall Acknowledgement Form even if they do not have the affected product in stock. Distributors were instructed to communicate the recall to any of their customers who may have received product included within the scope of the recall. Have the customers return any affected product to them, together with a completed Recall Acknowledgement Form. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 300 units
Distribution: Worldwide Distribution - US Distribution to the states of FL, GA, IL, KY, MA, MI, MO, MS, OH, TX, WA and WV., and to the countries of Canada and the Netherlands.
Product codes and lots: Catalog no. 5-22110, Lot no. 01M1300076.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1078-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1078-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-10

Product code BTR

K822082Class IISheridan/hvt,cf, UncuffedSheridan Catheter Corp. / cleared 1982-08-10

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)