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).
FDA Recall Z-1748-2011 · Posted 2011-03-23
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Recalling FirmGiven Imaging Ltd.
Recall StatusTerminated
Product CodeNEZ
Date Initiated2011-03-08
Date Terminated2011-12-02
Product Quantity389
Reason for Recall
The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval.
Firm 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.
Root Cause
Device Design
Distribution Pattern
U.S. Nationwide, Canada, Germany Israel and Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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