FDA Medical Device Recalls (openFDA)
Baxa Corporation: Exacta-Mix Valve Set, Primary Valve Assembly
- Recall number
- Z-0982-04
- Recalling firm
- Baxa Corporation
- Product
- Exacta-Mix Valve Set, Primary Valve Assembly
- Status
- Terminated
- Initiated
- 2004-04-30
- Posted
- 2004-07-20
- Terminated
- 2004-08-12
- Reason
- A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
- Root cause
- Other
- Action
- Consignees were notified by phone, fax and letter beginning 4/30/2004.
- Quantity
- 400 cases (10 per case)
- Distribution
- Nationwide, including 6 military hospitals and two VA facilities. Foreign distribution to Argentina, Brazil, Canada, Columbia, Hong Kong, Korea, Malaysia, Mexico, Panama, Singapore, Taiwan, UK, and Venezuela.
- Lot, serial or model codes
- Order No. REF: 711E
- 510(k) numbers
- ["K900585"]
- PMA numbers
- not on file
- Product code
- LHI
- Firm FEI
- 1419106
- Firm city
- Englewood
- Firm state
- CO
- 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