Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942
- Company
- Nova Biomedical Corporation
- Recall Initiated
- March 30, 2004
- Posted
- July 20, 2004
- Terminated
- June 17, 2004
- Recall Number
- Z-0826-04
- Quantity
- 35 units
- Firm Location
- Waltham, MA
Reason for Recall
Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
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 / Code Info
Domestic S/N: Y01C03200 Y01C03130 Y01104030 Y01104040 Y01104100 Y01104110 Y01304150 Y01304120 Y01104150 Y01104130 Y01104050 Y01104190 Y01104160 Y01104220 Y01204020 Y01204100 Y01204010 Y01204130 Y01204150 Y01204160 Y01703120 Y01304040 Y01304010 Y01304110 International S/N: Inst. S/N Y01204200 Y01304030 Y01304130 Y01304140 Y01304090 Y01304100 Y01104140 Y01204070 Y01204170 Y01104120 Y01C03150
Root Cause
Other
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.