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Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube… recallZ-0660-2012 · Smiths Medical ASD, Inc. · initiated Nov 28, 2011

Terminated All recalls posted in January 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0660-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 28, 2011
Posted by the FDA
Jan 19, 2012
Recalling firm
Smiths Medical ASD, Inc.
Quantity
US distribution 153,033 devices ; Foreign 21,490 devices
Product code
BTO
FDA submissions
K912469
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 description

Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped 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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Lot numbers: 1634475, 1646154, 1651839, 1672040, 1721272, 1729094, 1729106, 1749508, 1754749, 1770330, 1774597, 1778478, 1782866, 1782689, 1802344, 1809020, 1821941, 1825874, 1864872, 1875170, 1908871, 1914882, 1651837, 1667873, 1672039, 1675683, 1692771, 1679975, 1704685, 1708810, 1725218, 1729095, 1721273, 1737206, 1754750, 1774599, 1774598, 1802345, 1821942, 1829782, 1842384, 1856119, 1875171, 1887733, 1896161, 1904054, 1908872, 1646159, 1646155, 1672041, 1663914, 1667870, 1672036, 1679976, 1687696, 1692772, 1704687, 1704686, 1697000, 1721274, 1716554, 1729096, 1725219, 1725220, 1729107, 1741715, 1761966, 1749509, 1749510, 1757794, 1774600, 1770332, 1774601, 1774602, 1787319, 1802346, 1809021, 1821943, 1814053, 1829783, 1838634, 1851362, 1856120, 1870277, 1860806, 1883505, 1887734, 1887735, 1896162, 1914883, 1908873, 1651836, 1663919, 1667869, 1672038, 1679978, 1683722, 1704688, 1708811, 1725228, 1721275, 1733046, 1749511, 1757795, 1745563, 1757796, 1770333, 1774603, 1782869, 1782690, 1804334, 1809022, 1817444, 1825875, 1835015, 1842386, 1856121, 1860807, 1891548, 1908874, 1915870, and 1914884. With reorder numbers: 60NFP25, 60NFP30, 60NFP35, and 60NFP40.

Other devices under the same FDA submission

26 devices cleared under K912469 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 60449).

Sources and updates

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