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.
Reported: June 5, 2013 Initiated: May 2, 2013 #Z-1408-2013
Product Description
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.
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.
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 1,465
- Distribution
- USA Nationwide Distribution.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Merit Medical Systems, Inc.. Units affected: 1,465.
Why was this product recalled? ▼
Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2013. Severity: Moderate. Recall number: Z-1408-2013.
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