Recall Z-1598-2010
Ev3, Inc. · initiated March 31, 2010
Product
ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Nathan Lane North, Plymouth, MN 55442-2929. Intended as a palliative treatment of malignant neoplasms in the biliary tree.
Codes / lots: Lot Numbers: 7857377, 7856788 and 7858698.
Reason for recall
ev3 is conducting a voluntary recall on three lots of the Protg EverFlex" Biliary Stent System. They determined that a lot of 120mm Protg EverFlex" Biliary Stent system may contain a 150mm length Self-Expanding stent and two lots o 150mm Protg EverFlex" Biliary Stent System may contain a 120 mm length Self-Expanding stent.
FDA-determined cause: Mixed-up of materials/components
Action taken
ev3 issued "Medical Device Recall" notifications dated March 31, 2010 addressed to "Dear Risk Manager or Cath Lab Manager". Each letter addressed the affected product. Users were instructed to locate and remove from use the affected product and a sales representative will be in contact shortly to arrange for return. For further information, contact ev3 Customer Service at 1-800-716-6700.
Details
- Recall number
- Z-1598-2010
- Initiated
- March 31, 2010
- Posted by FDA
- May 13, 2010
- Terminated
- March 8, 2012
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Quantity
- 19
- Distribution
- Nationwide Distribution -- CA, FL, IL, LA, MA, MI, NH, PA, TN, TX, UT, VA and WA.
- Recalling firm
- Ev3, Inc., Plymouth, MN