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
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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
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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 |
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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 = FCG
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