FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Portex Thermovent T, Heat and Moisture Exchangers Catalog # 570016;
- Recall number
- Z-1129-04
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Portex Thermovent T, Heat and Moisture Exchangers Catalog # 570016;
- Status
- Terminated
- Initiated
- 2004-07-13
- Posted
- 2004-07-22
- Terminated
- 2012-05-08
- Reason
- Sterility of the device is compromised due to lack of package integrity
- Root cause
- Other
- Action
- Smiths Medical notified Direct Customers were contacted via letter delivered by Federal Express on July 13, 2004. Dealers were contacted via letter starting on July 14, 2004.Users are requested to return product.
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers 103166A, 103353A, 907001 to 912297, 001067 to 111623, K101587 to K522160
- 510(k) numbers
- ["K874597"]
- PMA numbers
- not on file
- Product code
- BYD
- Firm FEI
- 1217052
- Firm city
- Keene
- Firm state
- NH
- 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