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U.S. Department of Health and Human Services

Class 2 Device Recall PillCam Express Delivery Device

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  Class 2 Device Recall PillCam Express Delivery Device see related information
Date Initiated by Firm March 08, 2011
Date Posted March 23, 2011
Recall Status1 Terminated 3 on December 02, 2011
Recall Number Z-1748-2011
Recall Event ID 58137
510(K)Number K101200  
Product Classification endoscopic imaging device accessory - Product Code NEZ
Product Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak).
Code Information FGS# 0366, Lot number: 14081, 13688, 14097, 14144, 13783 and 13504, UPC: 7290101362050 and FGS# 0367, Lot number: 13438, 13690, 13781, 13806, 14082, 14095, 14099.14145, 14249, 14370, 14568, 14508 and 14787, UPC: 7290101362067.
Recalling Firm/
Manufacturer		 Given Imaging Ltd.
5555 Oakbrook Pkwy
Norcross GA 30093-6254
For Additional Information Contact Michael Silva, Sr.
770-662-0870
Manufacturer Reason
for Recall		 The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval.
FDA Determined
Cause 2		 Device Design
Action Given Imaging, Inc. consignees were notified via FedEx letter on/about 03/08/2011. They instructed to return all affected product. A Customer Response form with return instructions was included to be completed and returned to Given Imaging.
Quantity in Commerce 389
Distribution U.S. Nationwide, Canada, Germany Israel and Australia.
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 = NEZ and Original Applicant = GIVEN IMAGING LTD.
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