FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: 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.
- Recall number
- Z-0260-2007
- Recalling firm
- Smiths Medical ASD, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2006-11-17
- Posted
- 2006-12-07
- Terminated
- 2007-01-12
- Reason
- Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.
- Root cause
- Other
- Action
- 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.
- Quantity
- 5
- Distribution
- New York-single hospital consignee
- Lot, serial or model codes
- Lot CL47189.
- 510(k) numbers
- ["K923878"]
- PMA numbers
- not on file
- Product code
- JOH
- Firm FEI
- 1824231
- Firm city
- Gary
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28