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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 Devicesee related information
Date Initiated by FirmMarch 08, 2011
Date PostedMarch 23, 2011
Recall Status1 Terminated 3 on December 02, 2011
Recall NumberZ-1748-2011
Recall Event ID 58137
510(K)NumberK101200 
Product Classification endoscopic imaging device accessory - Product Code NEZ
ProductGiven 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.
FEI Number 3003141635
Recalling Firm/
Manufacturer		 Given Imaging Ltd.
5555 Oakbrook Pkwy
Norcross GA 30093-6254
For Additional Information ContactMichael 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
ActionGiven 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 Commerce389
DistributionU.S. Nationwide, Canada, Germany Israel and Australia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NEZ
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