FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm length 110 mm; REF 75HA60.
- Recall number
- Z-0394-06
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm length 110 mm; REF 75HA60.
- Status
- Terminated
- Initiated
- 2005-12-16
- Posted
- 2006-01-18
- Terminated
- 2007-02-08
- Reason
- Sterility is compromised by incomplete package seal.
- Root cause
- Other
- Action
- Certified letters were sent to each consignee on 12/ 16/05 and distributors were requested to notify their customers of the recall.
- Quantity
- not on file
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- Lot G706181.
- 510(k) numbers
- ["K922665"]
- 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