Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- September 13, 2013
- Posted
- October 22, 2013
- Terminated
- January 3, 2014
- Recall Number
- Z-0045-2014
- Quantity
- 200
- Firm Location
- South Jordan, UT
Reason for Recall
4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.
Distribution
US Distribution including the states of CO, VA, and MS.
Lot / Code Info
Part Number/Lot Number: 7560-43/I663860, 7560-43/I663861, 7560-G3/I664519 and 7560-G3/I666388.
Root Cause
Process control
Action Taken
Consignees were notified on 9/13/13 via Urgent Product Recall Notice, email, and product retrieval forms. Actions required of customers: 1. Please immediately determine if any of the devices are within your facility, quarantine them and discontinue use. 2. Ensure that all personnel to whom the devices were distributed are made aware of this field action. 3. Contact your Merit Sales Representative in order to arrange product return and replacement or credit. 4. If you have any questions concerning this communication, please don't hesitate to contact Guido Sandulli at 1-801-826-4046.