Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used
FDA device recall Z-1408-2013 · posted 2013-05-25 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 1,465
- Distribution
- USA Nationwide Distribution.
- Date initiated
- 2013-05-02
- Date posted
- 2013-05-25
- Date terminated
- 2013-07-22
- Location
- South Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER (K943739) | Mallinckrodt Medical | 1994-11-15 |