Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0624-2012

Lancelot 90 Degree with Cable Part Number ASC4145-01 is an ablation wand

Innovatech Medical Resources L.P. / initiated 2011-08-08 / Terminated / root cause: labeling and UDI

Innovatech Medical Resources L.P. began a recall of Lancelot 90 Degree with Cable Part Number ASC4145-01 is an ablation wand on . The reason FDA records is "Product is being removed from the field due to an over-label issue". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0624-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Innovatech Medical Resources L.P.
Product
Lancelot 90 Degree with Cable Part Number ASC4145-01 is an ablation wand
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall
Product is being removed from the field due to an over-label issue.
Root cause tag
labeling and UDI
FDA root cause
Reprocessing Controls
Action
Innovatech Medical Resources L.P. decided to recall all products resterilized and overlabeled at their facility. A firm representative would visit each customer and request that they remove the overlabeled product from their shelves and secure it. Customers could call the MSI office to get a RMA (Return Materials Authorization) for a refund on this product. For questions regarding this recall call 817-714-9066.
Quantity in commerce
3 units
Distribution
Nationwide Distribution including Texas
Product codes and lots
Lot Number N009660-A