RecallDepth

Stat Profile Critical Care Xpress CCX+ Analyzer Catalog Number: 37413

Company
Nova Biomedical Corporation
Recall Initiated
March 30, 2004
Posted
July 20, 2004
Terminated
June 17, 2004
Recall Number
Z-0827-04
Quantity
30 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 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

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.

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