Z-0656-2012

Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange)

Name: Z-0656-2012 Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange)
Creator: Smiths Medical ASD, Inc.
Published: 2011-11-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-11-28 / Terminated / root cause: design

FDA source

Smiths Medical ASD, Inc. began a recall of Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access... on 2011-11-28. The reason FDA records is "Difficulty disconnecting accessories from the Bivona Uncuffed Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0656-2012
Status: Terminated
Initiated: 2011-11-28
Posted: 2012-01-19
Terminated: 2014-10-17
Recalling firm: Abbott Medical
Product: Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse.
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
Reason for recall: Difficulty disconnecting accessories from the Bivona Uncuffed Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory, this may result in decannulation of the tube which could result in serious injury or death; especially if no replacement tracheostomy tube is imm
Root cause tag: design
FDA root cause: Device Design
Action: Smith Medical sent an Urgent Field Safety Notice dated November 28, 2011, via U.S. Mail to all affected consignees. The notice identified the product, description of problem, and actions to be taken. This notice included a Customer Information Bulletin and Urgent Field Safety Notice Confirmation Form. Customers were instructed to 1) identify all affected unused product in inventory and segregate it to a quarantine location; 2) complete and return the attached Confirmation Form by fax to 219-989-7259 or email to [email protected]; and 3) distributors were instructed to stop distributing and provide Smith Medical with a list of their customers, including contact details, so that Smith Medical can notify the customers of this notice. For questions contact Smiths Medical Customer Service at 800-258-5361, Option 1.
Quantity in commerce: US distribution 153,033 devices ; Foreign 21,490 devices
Distribution: Worldwide Distribution - USA Nationwide: AZ, CA, CO, CT,DE, FL, GA, HI, IL, IN, KS, KY, LA, SC, TX, OR, NJ, MO, UT, MI, NY, NM, MA, MN, MS, NC, ND, NE, NH, NV, OH, OK, OR, RI, SD, TN, VA, VT, WA, WI, WV including Washinton DC, Australia, Austria, Barbados, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gibraltar, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, New Zeland, Norway, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United States, Vatican City State
Product codes and lots: Lot numbers: 1648148, 1667782, 1675707, 1704654, 1721321, 1778519, 1796686, 1793516, 1774661, 1856219, 1868238, 1919159, 1644857, 1648155, 1655835, 1663879, 1679974, 1701034, 1696951, 1793517, 1796687, 1875211, 1919161, 1663892, 1671978, 1683687, 1793519, 1778473, 1809056, 1887784, 1896193, 1633576, 1642708, 1667809, 1651822, 1655831, 1663880, 1821993, and 1856220. Reorder number: 67SN025, 67SN030, 67SN035, and 67SN040.

Product code BTO

K912469Class IIBivona Wire Reinforced Pediatric Tracheostomy TubeBivona Medical Technologies / cleared 1991-06-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)