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U.S. Department of Health and Human Services

Class 2 Device Recall Expect Endoscopic Ultrasound Aspiration Needle

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  Class 2 Device Recall Expect Endoscopic Ultrasound Aspiration Needle see related information
Date Initiated by Firm October 20, 2010
Date Posted December 27, 2010
Recall Status1 Terminated 3 on August 03, 2011
Recall Number Z-0812-2011
Recall Event ID 57317
510(K)Number K100712  
Product Classification Biopsy Needle Kit - Product Code FCG
Product Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 25GA (0.52 mm) sterile, UPN M00550021, 5 pack, 428 Technology Drive East, Menomonie, WI.

Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Code Information Lot/Batch Number: 7442099.
Recalling Firm/
Manufacturer
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Cindy Finney
508-683-8000
Manufacturer Reason
for Recall
The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.
FDA Determined
Cause 2
Other
Action "Urgent Medical Device Recall - Immediate Action Required" notification letters were sent via Federal Express Priority mail on October 20, 2010. The letters identified the affected product and stated the reason for the recall. The notification instructs the account to immediately discontinue use of, 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.
Quantity in Commerce 567 all products
Distribution Worldwide Distribution -- US and Canada.
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 Corporation
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