Date Initiated by Firm | December 30, 2008 |
Date Posted | January 28, 2009 |
Recall Status1 |
Terminated 3 on October 30, 2009 |
Recall Number | Z-0912-2009 |
Recall Event ID |
50749 |
510(K)Number | K031538 |
Product Classification |
tubes, gastrointestinal - Product Code KNT
|
Product | Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6649, inner pouch UPN M00566490 and outer carton UPN M00566491.
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 M00566490) lots 12007899 and 12101506 packaged in outer cartons (UPN M00566491) with lot numbers of 12065904 and 12148450. |
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 | 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 |
|
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
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