Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- March 13, 2014
- Posted
- April 3, 2014
- Terminated
- July 7, 2014
- Recall Number
- Z-1320-2014
- Quantity
- 15
- Firm Location
- South Jordan, UT
Reason for Recall
The products are labeled as sterile but were not sterilized.
Distribution
Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
Lot / Code Info
Lot Number H574228
Root Cause
Release of Material/Component prior to receiving test results
Action Taken
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.