FDA Medical Device Recalls (openFDA)
Nova Biomedical Corporation: Stat Profile Critical Care Xpress CCX+ Analyzer Catalog Number: 37413
- Recall number
- Z-0827-04
- Recalling firm
- Nova Biomedical Corporation
- Product
- Stat Profile Critical Care Xpress CCX+ Analyzer Catalog Number: 37413
- Status
- Terminated
- Initiated
- 2004-03-30
- Posted
- 2004-07-20
- Terminated
- 2004-06-17
- Reason
- Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
- Root cause
- Other
- Action
- Nova Biomedical notified users by telephone on 3/31/04 and conducted follow-up by letter either by email or fax. On-site visit will be scheduled to replace the pump assembly.
- Quantity
- 30 units
- Distribution
- CA, IL, LA, MA ,NJ, NY, OH, PA, TX International: Italy ,England, Japan,Turkey., U.A.E., Greece, Thailand, Switzerland, Finland, Saudi Arabia, Italy, Mexico, Trinidad, Ireland, France, Cyprus, Czech Republic, ,Germany
- Lot, serial or model codes
- Domestic Serial Numbers: Y02C03170 Y02C03140 Y02C03180 Y02104060 Y02104180 Y02104070 Y02104210 Y02104080 Y02204180 International S/N: Y02204030 Y02204040 Y02204050 Y02204110 Y02204120 Y02204140 Y02204190 Y02304020 Y02C03190 Y02C03160 Y02C03090 Y02204060 Y02C03070 Y02304050 Y02C03050 Y02104090 Y02104230 Y02104170 Y02104020 Y02304070
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 1219029
- Firm city
- Waltham
- Firm state
- MA
- 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