Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.
This recall has been terminated (originally issued January 6, 2006).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- April 19, 2005
- Posted
- January 6, 2006
- Terminated
- December 6, 2007
- Recall Number
- Z-0338-06
- Quantity
- 11
- Firm Location
- Gary, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.
Distribution
California, Indiana and North Carolina.
Lot / Code Info
Lot G653628.
Root Cause
Other
Action Taken
Consignee was notified via recall letter dated April 19, 2005.
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