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Class 2 Device Recall Boston Scientific Endovive 20F (6.7 mm) Safety PEG Kit |
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Date Initiated by Firm |
December 30, 2008 |
Date Posted |
January 28, 2009 |
Recall Status1 |
Terminated 3 on October 30, 2009 |
Recall Number |
Z-0911-2009 |
Recall Event ID |
50749 |
510(K)Number |
K031538
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Product Classification |
tubes, gastrointestinal - Product Code KNT
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Product |
Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN M00566470 and outer carton UPN M00566471. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means. |
Code Information |
Inner pouch (UPN M00566470) lots 12004380, 12017735, 12039127, 12068485, 12074073, 1209443, 12115001, 12127100 and 12159831 Packaged in outer cartons (UPN M00566471) with lot numbers of 12069493, 12069494, 12112331, 12123598 and 12145424. |
Recalling Firm/ Manufacturer |
Boston Scientific Corp 780 Brookside Dr Spencer IN 47460-1080
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For Additional Information Contact |
508-683-4678
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Manufacturer Reason for Recall |
The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by "Urgent Medical Device Recall" letter dated 12/30/08. The letter described the problem with the product, instructed customers to determine whether they store these products in the outer carton or the inner pouch at their facility, to locate all affected products, and to return them to the firm. For additional information, contact Boston Scientific Corporation at 1-508-683-4678. |
Quantity in Commerce |
2460 of all products |
Distribution |
Nationwide. |
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 = KNT and Original Applicant = BOSTON SCIENTIFIC CORP.
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