Z-0045-2014Class II

Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3

Name: Z-0045-2014 Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3
Creator: Merit Medical Systems, Inc.
Published: 2013-09-13
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2013-09-13 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3 on 2013-09-13. FDA classified it as Class II and gives the reason as "4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0045-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-13
Posted: 2013-10-22
Terminated: 2014-01-03
Recalling firm: Merit Medical Systems, Inc.
Product: Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 200
Distribution: US Distribution including the states of CO, VA, and MS.
Product codes and lots: Part Number/Lot Number: 7560-43/I663860, 7560-43/I663861, 7560-G3/I664519 and 7560-G3/I666388.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0045-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0045-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-22

Product code DQO

K943739Class IISoftouch Diagnostic Intravascular CatheterMallinckrodt Medical / cleared 1994-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)