FDA Medical Device Recalls (openFDA)
Sorenson Medical, Inc.: Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE ***.
- Recall number
- Z-0496-03
- Recalling firm
- Sorenson Medical, Inc.
- Product
- Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE ***.
- Status
- Terminated
- Initiated
- 2002-11-25
- Posted
- 2003-01-30
- Terminated
- 2004-07-12
- Reason
- Catheters have 2 unvalidated seal product configurations to produce a new hybrid seal that had not been verified or validated.
- Root cause
- Other
- Action
- On 10/25/2002, all consignees were notified by letter.
- Quantity
- 2790 units
- Distribution
- Distributors in IL, OH, PA. Foreign distribution to Brazil, Czech Republic, Denmark, Guatemala, Italy.
- Lot, serial or model codes
- Product Code #220070, Lots 206082 and 206106.
- 510(k) numbers
- ["K961707"]
- PMA numbers
- not on file
- Product code
- BSY
- Firm FEI
- 1000117099
- Firm city
- West Jordan
- Firm state
- UT
- 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