FDA Recall
Terminated
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.
Recall: Z-0046-2007
·
Initiated August 11, 2006
Recall
- Recall Number
- Z-0046-2007
- Event Number
- 36148
- Firm
- Smiths Medical ASD, Inc.
- FEI Number
- 1824231
- Product Code
- JOH
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 11, 2006
- Posted
- October 19, 2006
- Terminated
- December 4, 2007
- Address
- 5700 W 23rd Ave, Gary, IN, 46406-2617
Description
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.
Reason
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.
Action
Consignees were notified to cease using, and to return the product, by recall letter dated August 2006 and mailed on 8/11/06.
Distribution
Nationwide.
Quantity
71 units.