ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB
FDA device recall Z-1598-2010 · posted 2010-05-13 · Terminated
Recall details
- Recalling firm
- Ev3, Inc.
- 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.
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 19
- Distribution
- Nationwide Distribution -- CA, FL, IL, LA, MA, MI, NH, PA, TN, TX, UT, VA and WA.
- Date initiated
- 2010-03-31
- Date posted
- 2010-05-13
- Date terminated
- 2012-03-08
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM (K060057) | Ev3, Inc. | 2006-03-08 |