Z-0162-2015Class II

Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package...

Name: Z-0162-2015 Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package...
Creator: Merit Medical Systems, Inc.
Published: 2014-09-26
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2014-09-26 / Terminated / root cause: labeling and UDI

FDA source

Merit Medical Systems, Inc. began a recall of Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged on 2014-09-26. FDA classified it as Class II and gives the reason as "These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0162-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-26
Posted: 2014-10-31
Terminated: 2014-11-19
Recalling firm: Merit Medical Systems, Inc.
Product: Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
Product code: KRA Catheter, Continuous Flush
Reason for recall: These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Consignees were notified via letter on September 26, 2014. Written notification included product identification information, instruction to immediately quarantine any devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative. An email notification was sent to US Merit sales representatives with accounts that had received affected product. The affected sales representatives were provided a Customer Response Form applicable to their account, a representative copy of communications sent directly to their affected accounts, and a copy of the Frequently Asked Questions. Merit sales representatives were instructed to visit the account and assist with the return of the affected units back to the Merit Field Assurance Department.
Quantity in commerce: 56 units
Distribution: Nationwide and to India. No govt/military/VA consignees.
Product codes and lots: Catalog No: 28MC24130ST, Lot H665694, H669824, Exp 2017 and Catalog No: 28MC24150SN, Lot H665696, Exp 7/31/2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0162-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0162-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-10-31

Product code KRA

K082613Class IIMerit MicrocatheterMerit Medical Systems, Inc. / cleared 2008-12-30

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)