Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.
This recall has been terminated (originally issued January 5, 2007).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- August 31, 2006
- Posted
- January 5, 2007
- Terminated
- May 4, 2007
- Recall Number
- Z-0339-2007
- Quantity
- 197
- Firm Location
- Gary, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.
Distribution
Worldwide Distribution ---- including USA states of Arkansas, California, Georgia, Illinois, Kansas, Minnesota, Missouri, Ohio, Pennsylvania, Texas and countries of Canada and Netherlands.
Lot / Code Info
Lots 1008187, 1023402 and 1012767.
Root Cause
Other
Action Taken
Distributors and hospital consignees were notified via recall letter dated 8/25/06 to return all unused product to the firm. Distributors were asked to notify their customers of the recall.
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