Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm, .35, 6Fr, OTW Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 REF SERB65-06-60-120 Lot 2675311 Use before 2009-01-01 Sterile EO Intended as a palliative treatment of malignant neoplasms in the biliary tree.
FDA Recall Z-2169-2008 · Posted 2008-08-26
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Recalling FirmEv3, Inc
Recall StatusTerminated
Product CodeFGE
Date Initiated2008-04-22
Date Terminated2011-12-10
Product Quantity1
Reason for Recall
A Protege PS Biliary stent system was mislabeled. The mislabeling resulted in a 9 mm diameter, 60 mm length stent being labeled as a 6 mm x 60 mm stent.
Firm Action
The single affected consignee was visited by an ev3 representative to verify the use of the device or exchange it for an unaffected device. Information recorded on an ev3 Device Reconciliation Form.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution --- state of LA.
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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