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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 21, 2004
Date Posted December 09, 2004
Recall Status1 Terminated 3 on October 13, 2005
Recall Number Z-0303-05
Recall Event ID 30489
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
Product NAMIC Custom Angiographic Kit, Left Heart Kit. - . Model #: H7496019054110. Catalog #601905411. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls, NY 12801.
Code Information 988046
Recalling Firm/
Manufacturer		 Boston Scientific Corp
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information Contact John Watkins
518-742-4411
Manufacturer Reason
for Recall		 The kits contains defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles.
FDA Determined
Cause 2		 Other
Action Two customers contacted via phone on 10/21/04 and 10/22/04, followed by letters dated 11/17/2004. Customers instructed to discontinue use and return product. Distributor instructed to notify customers.
Quantity in Commerce 24 kits
Distribution 2 customers in IL and NV.
Total Product Life Cycle TPLC Device Report
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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