FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
- Recall number
- Z-1465-2017
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
- Status
- Terminated
- Initiated
- 2017-02-09
- Posted
- not on file
- Terminated
- 2018-06-20
- Reason
- 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
- 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 smithsmedical4390@stericycle.com. 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: smithsmedical4390@stericycle.com.
- Quantity
- 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.
- Lot, serial or model codes
- 3272963
- 510(k) numbers
- ["K083641"]
- PMA numbers
- not on file
- Product code
- JOH
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28