—#71824

Product

CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, 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 V583783

Why it was recalled

Component of convenience kit may not be sterile.

Root cause (FDA determination)

Packaging

Action the firm took

The sole direct account (distributor) and the sole end-user were notified by letter on 03/13-14/2008. Direct account was instructed to return any affected product still in inventory. End user was advised to discard the blades or re-sterilize them according to blade manufacturer's instructions, which were included. For assistance, contact Merit Medical at 1-801-208-4349.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: PA. No military, government, or foreign distribution.

Timeline

Recall initiated: 2008-03-14
Posted by FDA: 2008-09-11
Terminated: 2008-09-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71824. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.