—#95525

Product

Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision A, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K913682
Affected lot / code info: Lot No.: F612578, F618688

Why it was recalled

Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.

Root cause (FDA determination)

Process control

Action the firm took

Merit issued an Urgent Product Recall Notice letter dated October 25, 2010 to consignees. Copnsignees were instructed to quarantine the product immediately for return and to notify customers of recall activity and instruct them to return product.. All distributors and customers are to complete and return a Recall Notification Form. For further information about this recall, contact Merit at 800 356-3748.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution in the states of CA, IL, IN, and UT.

Timeline

Recall initiated: 2010-10-25
Posted by FDA: 2010-12-08
Terminated: 2012-03-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95525. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.