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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 Recall
Novoste BetaCath 3.5F System
see related information
Date Posted January 30, 2003
Recall Status1 Open
Recall Number Z-0462-03
Recall Event ID 25139
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.
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, Georgia 30093
For Additional Information Contact Mr. Adam G. Lowe
770-717-0904
Manufacturer Reason
for Recall
Mislabeling. Source calibrated incorrectly, resultant dose rate lower than expected.
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.

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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