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U.S. Department of Health and Human Services

Class 3 Device Recall Expect Endoscopic Ultrasound Aspiration Needle

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  Class 3 Device Recall Expect Endoscopic Ultrasound Aspiration Needle see related information
Date Initiated by Firm August 11, 2011
Date Posted September 16, 2011
Recall Status1 Terminated 3 on November 10, 2011
Recall Number Z-3215-2011
Recall Event ID 59743
510(K)Number K100712  K110030  
Product Classification Kit needle biospy - Product Code FCG
Product Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EO

The Expect Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Code Information Lot: 13615651C1; UPN M00550020
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Cindy Finney
508-683-4678
Manufacturer Reason
for Recall		 The firm has determined that a single lot of 25 ga Expect EUS/FNA devices were mislabeled. The carton label incorrectly described the devices as 22 ga. The inner pouch label incorrectly describes the device as 25 ga.
FDA Determined
Cause 2		 Other
Action Boston Scientific Corporation sent a "URGENT MEDICAL DEVICE RECALL letter dated August 11, 2010, to all affected customers. The letter identified the product, the problem and the action needed to be taken by customer. Customers were instructed to immediately remove the affected lot of Recall products from your inventory ( whether in Labs, Central Supply, Shipping and Receiving or any other location). Also, segregate this product in a secure location for return to Boston Scientific. Complete and return the Reply Verification Tracking Form ( even if you do not have any product to return) following the directions on this page and Reply Verification Tracking Form. Fax the Form to (508) 683-5578. Further questions please call (508) 683-4678.
Quantity in Commerce 30 units
Distribution Nationwide Distribution including the states of VT, FL, SC, NC, WA, MA, and MN.
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 = FCG and Original Applicant = BOSTON SCIENTIFIC CORP.
510(K)s with Product Code = FCG and Original Applicant = Boston Scientific Corporation
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