Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942

FDA Recall Z-0826-04 · Posted 2004-07-20

Recalling FirmNova Biomedical Corporation
Recall StatusTerminated
Product CodeCHL
Date Initiated2004-03-30
Date Terminated2004-06-17
Product Quantity35 units

Reason for Recall

Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022746STAT PROFILE CRITICAL CARE XPRESS ANALYZERNova Biomedical Corp. · 2002-11-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑