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U.S. Department of Health and Human Services

Class 2 Device Recall Novoste BetaCath 3.5F System

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 Class 2 Device Recall Novoste BetaCath 3.5F Systemsee related information
Date Initiated by FirmJanuary 25, 2002
Date PostedJanuary 30, 2003
Recall Status1 Terminated 3 on November 17, 2003
Recall NumberZ-0462-03
Recall Event ID 25139
Product Classification unknown device name - Product Code JAJ
ProductNovoste, 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.
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
For Additional Information ContactMr. Adam G. Lowe
770-717-0904
Manufacturer Reason
for Recall		Mislabeling. Source calibrated incorrectly, resultant dose rate lower than expected.
FDA Determined
Cause 2		Other
ActionCustomers 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 Commerce50 units
DistributionNationwide. (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.
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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