Recalls / —
—#70434
Product
Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, 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 product code
- KDD — Kit, Surgical Instrument, Disposable
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Lot Number V477096
Why it was recalled
Sterility Compromised - Component of convenience kit was recalled by its manufacturer for non-sterility.
Root cause (FDA determination)
Packaging
Action the firm took
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.
Recalling firm
- Firm
- Merit Medical Systems, Inc.
- Address
- 1600 Merit Pkwy South, Jordan, Utah 84095-2416
Distribution
- Distribution pattern
- Class II Recall - Nationwide Distribution --- including state of NY.
Timeline
- Recall initiated
- 2008-04-10
- Posted by FDA
- 2008-09-19
- Terminated
- 2008-09-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #70434. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.