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U.S. Department of Health and Human Services

Class 3 Device Recall Boston Scientific

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 Class 3 Device Recall Boston Scientificsee related information
Date Initiated by FirmJune 17, 2008
Date PostedSeptember 17, 2008
Recall Status1 Terminated 3 on December 10, 2008
Recall NumberZ-2237-2008
Recall Event ID 48698
510(K)NumberK030855 
Product Classification Safety PEG Kit - Product Code KNT
ProductEndoVive Safety PEG Kits 20 F Universal Product Number (UPN): MOO566460 The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.
Code Information Lot Number: 11712923
FEI Number 3001451463
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
One Boston Scientific Place
Natick MA 01760
For Additional Information Contact
800-272-3737
Manufacturer Reason
for Recall		Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG
FDA Determined
Cause 2		Labeling mix-ups
ActionBoston Scientific notified customers by priority Express Mail on June 17, 2008. The notification instructs accounts to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Contact Boston Scientific Corporation at 1-800-272-3737 for assistance.
Quantity in Commerce16 Kits (total number of Kits)
DistributionNJ, SC, TN, VA, and WI
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KNT
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