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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps

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  Class 2 Device Recall Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps see related information
Date Initiated by Firm May 06, 2010
Date Posted June 04, 2010
Recall Status1 Terminated 3 on September 20, 2011
Recall Number Z-1772-2010
Recall Event ID 55740
Product Classification Forceps, biopsy, non-electric - Product Code FCL
Product Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps
Inner Pouch 240cm, Box 20
UPN/Catalog Number: M00513331
Code Information Lot : 13244654
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact SAME
508-683-8000
Manufacturer Reason
for Recall		 Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.
FDA Determined
Cause 2		 Process control
Action Boston Scientific issued Recall notification letters via Federal Express Priority mail on May 6, 2010. The notification instructs the account 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. In the letter, customers with questions are provided with a phone and email at the firm to contact.
Quantity in Commerce 320 units
Distribution Nationwide; Panama.
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.
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