Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.
This recall has been terminated (originally issued December 7, 2006).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- November 17, 2006
- Posted
- December 7, 2006
- Terminated
- January 12, 2007
- Recall Number
- Z-0260-2007
- Quantity
- 5
- Firm Location
- Gary, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.
Distribution
New York-single hospital consignee
Lot / Code Info
Lot CL47189.
Root Cause
Other
Action Taken
The consignee was notified of the problem via recall letter sent on 11/17/06 and given the options of continuing to use the product or of returning it.
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