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Class 2 Device Recall Boston Scientific Clipping Device, Resolution Clip |
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Date Initiated by Firm |
June 17, 2009 |
Date Posted |
September 02, 2009 |
Recall Status1 |
Terminated 3 on October 08, 2010 |
Recall Number |
Z-1895-2009 |
Recall Event ID |
52565 |
510(K)Number |
K040148
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Product Classification |
Endoscopic Clipping Device - Product Code FHN
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Product |
Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522600 (1 clip) and M00522602 (20 clips).
The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations. |
Code Information |
Product code M00522600, lot 0ML9042402 and Product code M00522602, lot 0ML9042701. |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 500 Commander Shea Blvd Quincy MA 02171-1518
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For Additional Information Contact |
800-272-3737
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Manufacturer Reason for Recall |
The clip may not deploy or, if deployed, the clip may not release from the tissue.
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FDA Determined Cause 2 |
Process control |
Action |
Consignees were notified by an "Urgent Recall Letter " dated June 17, 2009 and instructed to cease using the product because the calibration of equipment used to manufacture these products was not in control. This may potentially result in an inability to deploy or release the clip from the catheter. Consignees were instructed to return a business reply form for return authorization. Please contact Cindy Finney, Field Action Team Lead at 1-508-683-4678 for assistance. |
Quantity in Commerce |
217 |
Distribution |
Nationwide, France, Germany, Great Britain, Italy, Netherlands, Spain and Sweden. |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = FHN and Original Applicant = BOSTON SCIENTIFIC CORP.
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