Recall Z-0626-2011 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Ev3, Inc.
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.
| Date | Dec 16, 2010 (initiated Oct 30, 2010) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Packaging process control |
| 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. |
| Quantity | 30 |
| Distribution | Nationwide Distribution: including the states of AZ, DE, C, FL, GA, ID, IL, IN,LA, MN, MO, NJ, NY, NC, OH, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050725 | PROTEGE GPS SELF-EXPANDING NITINOL STENT Ev3 Corporation, Apr 20, 2005 |