CLASS II Device recall · Reported 4 Oct 2017 · FDA Enforcement Report
UniPerc(R) Adjustable Flange Tracheostomy Tube kit recalled
Smiths Medical ASD is recalling UniPerc(R) Adjustable Flange Tracheostomy Tube kit, distributed in Delaware. The recall was initiated on 14 Aug 2017 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-3213-2017
- FDA event ID
- 77957
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Aug 2017
- FDA classified
- 26 Sep 2017
- Reported
- 4 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 14 Aug 2017 | Recall initiated by company | |
| 26 Sep 2017 | Classified by FDA | +43 days |
| 4 Oct 2017 | 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 one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator.
Product as listed by the FDA
UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tubes are removed and may be replaced after no more than 30 days with an identical device. The range may include the following configurations: cuffed or uncuffed tracheostomy tubes, tracheostomy tube inner cannula, cleaning brushes and tracheostomy tube holder.
Where it was distributed
INTERNATIONAL ONLY: GB, FR, AT, DE, IT, SE, IE, BE, ES, LU
Questions about this recall
Why was it recalled?
Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator.
Which lots are affected?
Lot number 3308971
Where was it sold?
INTERNATIONAL ONLY: GB, FR, AT, DE, IT, SE, IE, BE, ES, LU
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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