Z-0826-04

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

Name: Z-0826-04 Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942
Creator: Nova Biomedical Corporation
Published: 2004-03-30
License: https://open.fda.gov/license/

Nova Biomedical Corporation / initiated 2004-03-30 / Terminated / root cause: manufacturing process

FDA source

Nova Biomedical Corporation began a recall of Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942 on 2004-03-30. The reason FDA records is "Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0826-04
Status: Terminated
Initiated: 2004-03-30
Posted: 2004-07-20
Terminated: 2004-06-17
Recalling firm: Nova Biomedical Corporation
Product: Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: 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

Product code CHL

K022746Class IIStat Profile Critical Care Xpress AnalyzerNova Biomedical Corp. / cleared 2002-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)