Recalls / —
—#49453
Product
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.
- FDA product code
- JOH — Tube Tracheostomy And Tube Cuff
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- 510(k) numbers
- K923878
- Affected lot / code info
- Lot CL47189.
Why it was recalled
Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Smiths Medical ASD, Inc.
- Address
- 5700 W 23rd Ave, Gary, Indiana 46406-2617
Distribution
- Distribution pattern
- New York-single hospital consignee
Timeline
- Recall initiated
- 2006-11-17
- Posted by FDA
- 2006-12-07
- Terminated
- 2007-01-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #49453. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.