ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot 4401432, Use Before 2010-07. The I
FDA device recall Z-1815-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Ev3, Inc
- Reason for recall
- Incorrect Label - an IntraCoil 5mm x 40 mm stent was labeled as a 5 mm x 60 mm stent (VT-5-40-135 was labeled as VT-5-60-135).
- Action taken
- ev3 representative retrieved from the consignnee the affected device on 4/4/08. A Device Reconcilliation Form was requested to be filled and returned with the product.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- NIP
- Quantity affected
- 3
- Distribution
- Nationwide Distribution including states of CA and MO.
- Date initiated
- 2008-04-02
- Date posted
- 2008-09-11
- Date terminated
- 2011-12-10
- Location
- Plymouth, MN
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