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.
FDA Recall Z-1809-2008 · Posted 2008-09-19
Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeKDD
Date Initiated2008-04-10
Date Terminated2008-09-22
Product Quantity30 Kits
Reason for Recall
Sterility Compromised - Component of convenience kit was recalled by its manufacturer for non-sterility.
Firm 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.
Root Cause
Packaging
Distribution Pattern
Class II Recall - Nationwide Distribution --- including state of NY.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.