Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- May 2, 2013
- Posted
- May 25, 2013
- Terminated
- July 22, 2013
- Recall Number
- Z-1408-2013
- Quantity
- 1,465
- Firm Location
- South Jordan, UT
Reason for Recall
Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.
Distribution
USA Nationwide Distribution.
Lot / Code Info
Lot Numbers: 1662386, 1662390, 1662385, 1662387, 1662391
Root Cause
Process control
Action Taken
Merit sent an Urgent Product Recall Notice letter dated May 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to identify, quarantine, discontinue using products, and contact their sales representative to arrange product return and replacement or credit. For questions call 1-801-208-4468.
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