ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only. ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 12 mm 60mm 80 cm, REF SERB65-12-60-80, Rx only.
FDA Recall Z-0626-2011 · Posted 2010-12-16
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Recalling FirmEv3, Inc.
Recall StatusTerminated
Product CodeFGE
Date Initiated2010-10-30
Date Terminated2012-03-29
Product Quantity30
Reason for Recall
Mislabeled size: Specific Protg GPS lots have product labeling that does not match the actual stent sizes contained in the packages. The affected product outer packaging is labeled as a 12 mm x 60 mm Protg GPS stent but contains a 14 mm x 60 mm stent. This situation can potentially result in vessel damage. Conversely, a lot was labeled as a 14 mm x 60 mm Protg GPS stent but actually contai
Firm Action
ev3 issued a "Medical Device Recall" letter dated September 29, 2010 to consignees. The letter described the product, Issue Summary, & Required Action. Consignees are to review inventory and remove all affected devices. ev3 representatives will contact customers to arrange for the return and credit of unused product.
ev3 can be reached at 800 716-6700 concerning this recall.
Root Cause
Packaging process control
Distribution Pattern
Nationwide Distribution: including the states of AZ, DE, C, FL, GA, ID, IL, IN,LA, MN, MO, NJ, NY, NC, OH, VA, and WA.
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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