Recall Z-0826-04 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Nova Biomedical Corporation
Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942
| Date | Jul 20, 2004 (initiated Mar 30, 2004) |
| Status | Terminated |
| 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 | 35 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022746 | STAT PROFILE CRITICAL CARE XPRESS ANALYZER Nova Biomedical Corp., Nov 22, 2002 |