Recall Z-0618-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Innovatech Medical Resources L.P.
CoVac 50 Product Number AS2530-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
| Date | Jan 11, 2012 (initiated Aug 8, 2011) |
| Status | Terminated |
| Reason | Product is being removed from the field due to an over-label issue. |
| 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 | Lot Number (QTY): 3018831-2 (1 unit) and 3014221 (1 unit) |
| Distribution | Nationwide Distribution including Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082980 | ARTHROCARE ARTHROWANDS Arthrocare Corp., Nov 5, 2008 |