Z-1465-2017Class II

Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035

Name: Z-1465-2017 Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035
Creator: Smiths Medical ASD Inc.
Published: 2017-02-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-02-09 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD Inc. began a recall of Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035 on 2017-02-09. FDA classified it as Class II and gives the reason as "Smiths Medical became aware that one lot of the Bivona 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use". 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-1465-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-09
Posted: 2017-03-14
Terminated: 2018-06-20
Recalling firm: Abbott Medical
Product: Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Smiths Medical became aware that one lot of the Bivona 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Consignees were sent a Smiths Medical "Urgent Medical Device Field Safety Notice" dated February 08, 2017. The letter was addressed to "Clinician". The letter listed the Affected devices, Reason for Recall, Risk to Health, and Instructions to Customers. Advised customers to complete and return the "Urgent Medical Device Field Safety Notice (FSN) Response Form" to [email protected]. All affected devices must be returned to Stericycle for processing. If the product was further distributed, consignees were asked to immediately notify them of the Recall and retrieve all affected devices. For questions contact Stericycle via e-mail at the following address: [email protected].
Quantity in commerce: 142
Distribution: US: CA, ILM NC, GA, NE, MA, CO, CT, MO, TN, LA, MD, MN, FL, SC,M OK, MI, PA, TX, WA, WI.
Product codes and lots: 3272963

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1465-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1465-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-14

Product code JOH

K083641Class IIBivona Tracheostomy TubesSmiths Medical Asd, Inc. / cleared 2009-02-23

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