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Class 2 Device Recall Novoste BetaCath 3.5F System |
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Date Initiated by Firm |
January 25, 2002 |
Date Posted |
January 30, 2003 |
Recall Status1 |
Terminated 3 on November 17, 2003 |
Recall Number |
Z-0462-03 |
Recall Event ID |
25139 |
Product Classification |
unknown device name - Product Code JAJ
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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.
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Code Information |
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. |
Recalling Firm/ Manufacturer |
Novoste Corporation 3890 Steve Reynolds Blvd. Norcross GA 30093
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For Additional Information Contact |
Mr. Adam G. Lowe 770-717-0904
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Manufacturer Reason for Recall |
Mislabeling. Source calibrated incorrectly, resultant dose rate lower than expected.
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FDA Determined Cause 2 |
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. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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