Reported Oct 4, 2017 · Terminated
UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can…
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- 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 configurationscuffed or uncuffed tracheostomy tubes, tracheostomy tube inner cannula, cleaning brushes and tracheostomy tube holder
- Lot codes and dates
- Lot number 3308971
- Amount recalled
- 89 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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