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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-1063-03
Recall Event ID 26713
Product ASAP Channel Cut Biopsy System, 18 gauge
Reference Number: 1394
Code Information 4105648 4113988 4162641 4193798 4206664 4231542 4266299 4290089 4297846 4339339 4363204 4387477 4401411 4414613 4472494 4494612 4506626 4528577 4555320 4591333 4611363 4646473 4671080 4732694 4776718 4792615 4814439 4916050 4923749 4940371 4955250 5000456 5025458 5048339 5071211 5086862 5153158 5190439 5226638 5280768 5313310 5340135 5343856 5347420 5374497 5388620 5395693 5446265 
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 2505 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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