Recalls / —

—#126485

Product

Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.

FDA product code

FMF — Syringe, Piston

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K875196

Affected lot / code info

Lot Number H574228

Why it was recalled

The products are labeled as sterile but were not sterilized.

Root cause (FDA determination)

Release of Material/Component prior to receiving test results

Action the firm took

Merit Medical sent an Urgent Product Recall Notice dated March 14, 2014 to all customers and sales representatives via email. The letter identified the affected product, problem and actions to be taken. Customers were provided a Product Retrieval Form, product identification information, instruction to immediately quarantine any devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative to arrange product return and replacement. For questions call 1-801-316-4822.

Recalling firm

Firm

Merit Medical Systems, Inc.

Address

1600 West Merit Parkway, South Jordan, Utah 84095

Distribution

Distribution pattern

Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.

Timeline

Recall initiated

2014-03-13

Posted by FDA

2014-04-03

Terminated

2014-07-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #126485. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.