Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Ca
FDA device recall Z-0378-2007 · posted 2007-01-25 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KAC
- Quantity affected
- 117
- Distribution
- Worldwide, including USA, Canada, Netherlands and United Kingdom.
- Date initiated
- 2006-12-15
- Date posted
- 2007-01-25
- Date terminated
- 2007-12-04
- Location
- Gary, IN
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