Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
FDA device recall Z-0045-2014 · posted 2013-10-22 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 200
- Distribution
- US Distribution including the states of CO, VA, and MS.
- Date initiated
- 2013-09-13
- Date posted
- 2013-10-22
- Date terminated
- 2014-01-03
- Location
- South Jordan, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER (K943739) | Mallinckrodt Medical | 1994-11-15 |