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Terminated

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.

FDA Recall Z-0462-03 · Posted 2003-01-30

Recalling FirmNovoste Corporation
Recall StatusTerminated
Product CodeJAJ
Date Initiated2002-01-25
Date Terminated2003-11-17
Product Quantity50 units

Reason for Recall

Mislabeling. Source calibrated incorrectly, resultant dose rate lower than expected.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

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

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