—#70437

Product

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 product code: KDD — Kit, Surgical Instrument, Disposable
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Number V477095

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 #70437. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.