Recall Z-1809-2008 ยท KDD Kit, Surgical Instrument, Disposable
Merit Medical Systems, Inc.
Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02159A, Sterile, 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 19, 2008 (initiated Apr 10, 2008) |
| Status | Terminated |
| Reason | Sterility Compromised - Component of convenience kit was recalled by its manufacturer for non-sterility. |
| Root cause | Packaging |
| Action | Site Visit - There is only one consignee that received product. That single consignee was visited by Merit sales rep on 04/14/2008 with instructions to discontinue use and quarantine any affected product. No Hemovac inventory and no affected kits remained in Merit's inventory at the time of notification from Zimmer. The consignee site representative verified that all 60 of the affected kits received by them had already been used. |
| Quantity | 30 Kits |
| Distribution | Class II Recall - Nationwide Distribution --- including state of NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.