Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.
This recall has been terminated (originally issued January 25, 2007).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- December 15, 2006
- Posted
- January 25, 2007
- Terminated
- December 4, 2007
- Recall Number
- Z-0378-2007
- Quantity
- 117
- Firm Location
- Gary, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.
Distribution
Worldwide, including USA, Canada, Netherlands and United Kingdom.
Lot / Code Info
Lots 1055779, 1245930, 1263830, 1302670, 1310500, 1324570, 1351420, 1351480, G654810, G689730 and G726388.
Root Cause
Other
Action Taken
Consignees were notified via recall letter dated 12/15/06. Distributors were requested to provide the firm with final user name and address information so that they could notify them of the recall. The firm is advising users that they can either return the product for replacement or continue to use it now that they are aware of the labeling error.
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