FDA Medical Device Recalls (openFDA)
Portex, Inc: Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40.
- Recall number
- Z-0927-03
- Recalling firm
- Portex, Inc
- Product
- Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40.
- Status
- Terminated
- Initiated
- 2003-02-20
- Posted
- 2003-06-12
- Terminated
- 2003-12-10
- Reason
- May have incorrectly printed graduation markings along the tube shaft.
- Root cause
- Other
- Action
- A recall letter dated February 20, 2003 was issued to each customer. Customers were instructed to cease use of the lot and to return the product to Portex.
- Quantity
- 49
- Distribution
- Nationwide, England and France
- Lot, serial or model codes
- Lot 1134710
- 510(k) numbers
- ["K894613","K894614","K922665"]
- PMA numbers
- not on file
- Product code
- KOH
- 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