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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific 24F (8 mm) Standard PEG Kit

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  Class 2 Device Recall Boston Scientific 24F (8 mm) Standard PEG Kit see related information
Date Initiated by Firm May 05, 2009
Create Date June 25, 2015
Recall Status1 Terminated 3 on October 13, 2010
Recall Number Z-1631-2009
Recall Event ID 52189
510(K)Number K031538  
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
Product Boston Scientific EndoVive 24F (8 mm) Standard PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; inner pouch UPN M00568250 and outer carton UPN M00568251.

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 UPN M00568250 and UPN M00568251 Lot Numbers: 11942230, 11988701, 12043256, 12116837 and 12159829.
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact
508-683-4678
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.
FDA Determined
Cause 2		 Process control
Action Boston Scientific Corporation issued an "Urgent Medical Device Recall - Immediate Action Required" notice dated May 5, 2009 as follow-up to their "Recall of the Safety and Standard Push PEG Kits" dated December 30, 2008. The notice outlined the issue and Consignees were instructed to locate and return all affected product to the firm. In addition, the firm requests that users complete and return a Reply Verification Tracking Form via fax to 1-508-683-5578. For further questions, contact the Boston Scientific Corporation Field Action Team by phone at 1-508-683-4678.
Quantity in Commerce 238
Distribution Worldwide Distribution -- United States, India, Japan and Slovenia.
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 = KNT and Original Applicant = BOSTON SCIENTIFIC CORP.
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