Stat Profile Critical Care Xpress CCX+ Analyzer Catalog Number: 37413
FDA device recall Z-0827-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Nova Biomedical Corporation
- Reason for recall
- Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 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 R
- Date initiated
- 2004-03-30
- Date posted
- 2004-07-20
- Date terminated
- 2004-06-17
- Location
- Waltham, MA
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