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.
Recall
- Recall Number
- Z-0462-03
- Event Number
- 25139
- Firm
- Novoste Corporation
- FEI Number
- 3000205626
- Product Code
- JAJ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 25, 2002
- Posted
- January 30, 2003
- Terminated
- November 17, 2003
- Address
- 3890 Steve Reynolds Blvd., Norcross, GA, 30093
Description
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.
Mislabeling. Source calibrated incorrectly, resultant dose rate lower than expected.
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.
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.
50 units