Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths Medical Critical Care; REF 60A160.
This recall has been terminated (originally issued October 19, 2006).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- August 11, 2006
- Posted
- October 19, 2006
- Terminated
- December 4, 2007
- Recall Number
- Z-0046-2007
- Quantity
- 71 units.
- Firm Location
- Gary, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.
Distribution
Nationwide.
Lot / Code Info
Lots 1037018 and 1045416.
Root Cause
Other
Action Taken
Consignees were notified to cease using, and to return the product, by recall letter dated August 2006 and mailed on 8/11/06.
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