—#52154

Product

Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP, Merit Medical Systems, Inc., South Jordan, Utah 84095.

FDA product code: FMG — Stopcock, I.V. Set
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K915678
Affected lot / code info: Lot Number F524277

Why it was recalled

Male luer in fluid administration sets may crack due to inadequate molding process

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter on 04/17/2007 and instructed to quarantine and return any unused product.

Recalling firm

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

Distribution

Distribution pattern: CA, IL, NJ, NY. No military, government or foreign distribution.

Timeline

Recall initiated: 2007-04-17
Posted by FDA: 2007-05-31
Terminated: 2008-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #52154. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.