—#73736

Product

Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K913682
Affected lot / code info: Lot number F622787

Why it was recalled

Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at 801-208-4748.

Root cause (FDA determination)

Process control

Action the firm took

All consignees were notified by sales reps via phone, fax or visit between 09/15/2008 and 10/09/2008. Sales reps were to instruct them to immediately discontinue use and quarantine all affected products. A Product Retrieval Form was to be completed and signed by the customer's site representative. More information available at 801-316-4998.

Recalling firm

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

Distribution

Distribution pattern: United States including the states of AR, AZ, CA, CO, FL, KY, IL, IN, MA, MI, MN, MO, NJ, NY, PA, SC, TX, UT, VA, WI, and WV. No military or foreign distribution. VA facilities in CA and FL.

Timeline

Recall initiated: 2008-09-12
Posted by FDA: 2009-01-13
Terminated: 2009-01-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73736. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.