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.
Recall
- Recall Number
- Z-1809-2008
- Event Number
- 47881
- Firm
- Merit Medical Systems, Inc.
- FEI Number
- 1721504
- Product Code
- KDD
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- April 10, 2008
- Posted
- September 19, 2008
- Terminated
- September 22, 2008
- Address
- 1600 Merit Pkwy South, Jordan, UT, 84095-2416
Description
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.
Sterility Compromised - Component of convenience kit was recalled by its manufacturer for non-sterility.
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.
Class II Recall - Nationwide Distribution --- including state of NY.
30 Kits