—#85857

Product

Merit Medical Systems, Inc. Monarch Inflation Syringe label reading in part: MONARCH CATALOG NUMBER IN2130 for inflation and deflation of interventional devices

FDA product code: DXT — Injector And Syringe, Angiographic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K884913
Affected lot / code info: Lot # F730935

Why it was recalled

Potential sterility breach caused by excessive shipment damage.

Root cause (FDA determination)

Other

Action the firm took

Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.

Recalling firm

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

Distribution

Distribution pattern: US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.

Timeline

Recall initiated: 2009-09-29
Posted by FDA: 2009-12-14
Terminated: 2009-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85857. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.