Recall Z-1816-2008
Ev3, Inc · initiated April 9, 2008
Product
ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07.
Codes / lots: Lot 4401214
Reason for recall
An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent.
FDA-determined cause: Labeling mix-ups
Action taken
ev3 representative visited the consignee on 4/15/08 and spoke to the physician at the site that used the device. A Device Recall Field Action Reconcilliation Form was requested.
Details
- Recall number
- Z-1816-2008
- Initiated
- April 9, 2008
- Posted by FDA
- September 21, 2008
- Terminated
- May 27, 2009
- Product code
- NIP – Stent, Superficial Femoral Artery
- Quantity
- 1
- Distribution
- CA
- Recalling firm
- Ev3, Inc, Plymouth, MN