CLASS II Device recall · Reported 3 Mar 2021 · FDA Enforcement Report
Tube Tracheostomy and Tube Cuff recalled by Smiths Medical ASD
Smiths Medical ASD is recalling Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend", distributed nationwide in the US. The recall was initiated on 18 Jan 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1145-2021
- FDA event ID
- 87192
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jan 2021
- FDA classified
- 23 Feb 2021
- Reported
- 3 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 18 Jan 2021 | Recall initiated by company | |
| 23 Feb 2021 | Classified by FDA | +36 days |
| 3 Mar 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. As a result, there is potential for patient injury if an incorrect device or accessory is selected for use. This use could lead to an internal injury resulting from excessive device contact with tissue, or an external patient injury due to external portions of the device pressing into or rubbing against tissue.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed for single-patient use up to 5 times.
Where it was distributed
US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TX, UT, VA, and WA.
Nationwide AlabamaArizonaCaliforniaConnecticutFloridaGeorgiaIowaIllinoisKansasKentuckyLouisianaMassachusettsMaineMichiganMinnesotaMissouriNorth CarolinaNew JerseyNew YorkOhio
Questions about this recall
Why was it recalled?
Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. As a result, there is potential for patient injury if an incorrect device or accessory is selected for use. This use could lead to an internal injury resulting from excessive device contact with tissue, or an external patient injury due to external portions of the device pressing into or rubbing against tissue.
Which lots are affected?
model 60PFS45, lots 3991171 (202 units), 3991172 (117 units), and 3988103 (229 units).
Where was it sold?
US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TX, UT, VA, and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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