Z-2114-2018Class II

Bivona Tracheostomy Tube Tracheostomy Tubes

Name: Z-2114-2018 Bivona Tracheostomy Tube Tracheostomy Tubes
Creator: Smiths Medical ASD Inc.
Published: 2018-04-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-04-02 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD Inc. began a recall of Bivona Tracheostomy Tube Tracheostomy Tubes on 2018-04-02. FDA classified it as Class II and gives the reason as "Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile". 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-2114-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-02
Posted: 2018-06-07
Terminated: 2018-11-14
Recalling firm: Abbott Medical
Product: Bivona Tracheostomy Tube Tracheostomy Tubes
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
Reason for recall: Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Customers were notified via letter on approximately 04/02/2018. Instructions included to determine if there are any affected Customized Bivona Tracheostomy Tubes in inventory, notify customers if the devices have been further distributed, arrange for the return of affected devices, and complete and return the acknowledgement response form.
Quantity in commerce: 16 units
Distribution: Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.
Product codes and lots: Part No. (Lot No.): CMZ3241N (DS009716), ST16EN80NSC194N (DS009794), SU15AN70NSC153N (DS009577), FT17IN60NGC114N (DS009894), CMZ3331N (DS009761), XU17GS50NSF046N (DS009609), FT17IN60NGC114N (DS009861), AA16ES70NSC110N (DS009586), FT17IN70NSC111N (DS009856), FT16IN60NGC053N (DS009540), FU15AN55NSA076N (DS009464), AT17IS60NGC105N (DS009811)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2114-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2114-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07

Product code BTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)