Recall Z-0614-2014
Merit Medical Systems, Inc. · initiated December 6, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.
Codes / lots: Catalog Numbers: 28MC24110ST with Lot Number: H548211, and Catalog Number: 28MC24130SN with Lot Numbers: H549598, or H553237
Reason for recall
Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match.
FDA-determined cause: Packaging process control
Action taken
Merit Medical Systems sent an Urgent Product Recall Notice dated December 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use of the Maestro Microcatheters identified and isolate them in a quarantined area until the product is over-labeled by their Merit Sales Representative Customers were instructed to ensure that all personnel to whom the devices were distributed were made aware of the field action. Customers with questions were instructed to contact their sales representative or call 1-801-826-4062. For questions regarding this recall call 801-253-1600.
Details
- Recall number
- Z-0614-2014
- Initiated
- December 6, 2013
- Posted by FDA
- December 31, 2013
- Terminated
- January 27, 2014
- Product code
- KRA – Catheter, Continuous Flush
- Quantity
- 59
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada.
- Recalling firm
- Merit Medical Systems, Inc., South Jordan, UT