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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific RunWay Guide Catheter

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  Class 2 Device Recall Boston Scientific RunWay Guide Catheter see related information
Date Initiated by Firm March 03, 2014
Date Posted March 10, 2014
Recall Status1 Terminated 3 on June 09, 2014
Recall Number Z-1164-2014
Recall Event ID 67658
510(K)Number K033441  
Product Classification Catheter, percutaneous - Product Code DQY
Product Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Code Information 2013040058
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Brent Hathcock
763-494-1133
Manufacturer Reason
for Recall		 The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.
FDA Determined
Cause 2		 Packaging
Action Consignees were sent a Boston Scientific "Urgent Medical Device Recall Removal " letter dated March 3, 2014. The letter described the problem and the product involved in the recall. The letter advised consignees to return the affected product and to complete and return the Account Reply Verification Tracking Form. The local Sales Representative can answer any questions that you may have regarding this Recall Removal.
Quantity in Commerce 7
Distribution TX and Russia
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 = DQY and Original Applicant = BOSTON SCIENTIFIC CORP.
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