Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80.
This recall has been terminated (originally issued January 18, 2006).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- December 16, 2005
- Posted
- January 18, 2006
- Terminated
- February 8, 2007
- Recall Number
- Z-0395-06
- Firm Location
- Gary, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility is compromised by incomplete package seal.
Distribution
Nationwide and Canada.
Lot / Code Info
Lots G711870 and G711871.
Root Cause
Other
Action Taken
Certified letters were sent to each consignee on 12/ 16/05 and distributors were requested to notify their customers of the recall.
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