Z-0462-03

Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST)...

Name: Z-0462-03 Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST)...
Creator: Novoste Corporation
Published: 2002-01-25
License: https://open.fda.gov/license/

Best Vascular, Inc. / initiated 2002-01-25 / Terminated / root cause: labeling and UDI

FDA source

Novoste Corporation began a recall of Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST), Novoste Corporate, 3890 Steve Reynolds Blvd, Norcross... on 2002-01-25. The reason FDA records is "Mislabeling. Source calibrated incorrectly, resultant dose rate lower than expected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0462-03
Status: Terminated
Initiated: 2002-01-25
Posted: 2003-01-30
Terminated: 2003-11-17
Recalling firm: Best Vascular, Inc.
Product: Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST), Novoste Corporate, 3890 Steve Reynolds Blvd, Norcross, GA 30093, Tel: +1770-717-0904, Fax: +1770-717-1283, 1-800-NOVOSTE (1-800-668-6783), www.novoste.com.
Product code: JAJ
Reason for recall: Mislabeling. Source calibrated incorrectly, resultant dose rate lower than expected.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Customers were notified via Advisory Letter followed up with a Recall Letter and Customer Informational Letter on/about January 24, 2002. Customers were advised to discontinue use of the product and return the affected product to Novoste Corp. to be recalibrated to obtain a correct calibration certificate.
Quantity in commerce: 50 units
Distribution: Nationwide. (AR, AZ, CA, FL, GA, IA, ID, IL, KY, MD, MI, MN, MO, NC, NM, NV, NY, OH, PA, TN, TX, VA, WA). No foreign or government accounts involved.
Product codes and lots: Catalog Numbers: TDA-0030 - Serial Numbers: 81431, 81761, 82548, 83007, 83926, 84395, 85014, 85021, 86333, 86489, 86874, 86889, 86897, 87097, 87103, 87189, 88592, 88692, 88734, 88738, 89035, 89037, 89058, TDA-0040- Serial Numbers: 77252, 81012, 83214, 85327, 87816, 87834, 88591, 88598, 88617, 88622, 88626, 88632, 88681, 88697, 88691, 88697, 88702, 88712, 88718, 88719, 88720, 88721, 88736, 88739, 89045, 89049, 89054.

Product code JAJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)