Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
FDA Recall Z-0045-2014 · Posted 2013-10-22
Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2013-09-13
Date Terminated2014-01-03
Product Quantity200
Reason for Recall
4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.
Firm Action
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
Distribution Pattern
US Distribution including the states of CO, VA, and MS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.