Recall Z-2197-2008 ยท KDD Kit, Surgical Instrument, Disposable
Merit Medical Systems, Inc.
CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products' intended uses.
| Date | Sep 11, 2008 (initiated Mar 14, 2008) |
| Status | Terminated |
| Reason | Component of convenience kit may not be sterile. |
| Root cause | Packaging |
| Action | The sole direct account (distributor) and the sole end-user were notified by letter on 03/13-14/2008. Direct account was instructed to return any affected product still in inventory. End user was advised to discard the blades or re-sterilize them according to blade manufacturer's instructions, which were included. For assistance, contact Merit Medical at 1-801-208-4349. |
| Quantity | 36 kits |
| Distribution | PA. No military, government, or foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.