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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-1062-03
Recall Event ID 26713
Product ASAP Channel Cut Biopsy System, 15 gauge
Reference Number: 1390
Code Information 4097154 4126946 4145035 4158456 4193792 4212753 4221510 4231545 4256164 4262043 4258584 4282986 4313907 4323261 4349628 4375687 4392520 4405118 4408527 4414677 4425997 4464404 4464403 4468969 4494611 4528589 4537936 4550692 4557360 4562655 4579693 4583642 4625634 4628069 4639625 4652811 4689625 4701139 4701138 4727026 4742360 4764119 4764122 4774555   4788365 4823397 4830419 4845754 4900789 4910488 4915451 4935096 4963935 4963936 4983393 4992627 5007857 5019451 5022419 5038639 5065152 5121437 5129514 5140440 5155296 5158742 5169243 5173373 5182914 5186852 5205601 5223778 5227258 5238638 5246424 5251510 5269078 5288531 5301576 5320588 5371233 5427428 5440613 5473223 5501877 5505775 5511863 5547602  
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 b e 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 9455 units
Distribution Nationwide

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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