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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific /Micorvasive

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  Class 2 Device Recall Boston Scientific /Micorvasive see related information
Date Initiated by Firm July 03, 2003
Date Posted July 29, 2003
Recall Status1 Terminated 3 on June 17, 2004
Recall Number Z-1061-03
Recall Event ID 26713
510(K)Number K935814  
Product Classification Instrument, Biopsy - Product Code KNW
Product ASAP Channel Cut Biopsy System, 14 gauge
Reference Number: 1250
Code Information 4104836, 4145036, 4211323, 4290090 ,4370503 4405122, 4445839, 4461241, 4569317, 4666229 4916051, 5022356, 5120746, 5133248, 5251508,  5288530
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Place
Natick MA 01760
For Additional Information Contact Robert T. Miragliuolo
508-652-5186
Manufacturer Reason
for Recall		 Sterility of the device may be compromised due to a lack of package integrity
FDA Determined
Cause 2		 Other
Action Boston Scientific notified accounts by letter on 7/3/03. Accounts are requested to check inventory and return product. A Veification Form was requested to be completed.
Quantity in Commerce 1,030 units
Distribution Nationwide
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.
510(K) Database 510(K)s with Product Code = KNW and Original Applicant = BOSTON SCIENTIFIC CORP.
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