Z-1320-2014Class II

Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO

Name: Z-1320-2014 Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO
Creator: Merit Medical Systems, Inc.
Published: 2014-03-13
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2014-03-13 / Terminated / root cause: labeling and UDI

FDA source

Merit Medical Systems, Inc. began a recall of Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO on 2014-03-13. FDA classified it as Class II and gives the reason as "The products are labeled as sterile but were not sterilized". 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-1320-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-13
Posted: 2014-04-03
Terminated: 2014-07-07
Recalling firm: Merit Medical Systems, Inc.
Product: Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Product code: FMF Syringe, Piston
Reason for recall: The products are labeled as sterile but were not sterilized.
Root cause tag: labeling and UDI
FDA root cause: Release of Material/Component prior to receiving test results
Action: Merit Medical sent an Urgent Product Recall Notice dated March 14, 2014 to all customers and sales representatives via email. The letter identified the affected product, problem and actions to be taken. Customers were provided a Product Retrieval Form, 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 to arrange product return and replacement. For questions call 1-801-316-4822.
Quantity in commerce: 15
Distribution: Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
Product codes and lots: Lot Number H574228

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1320-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1319-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-04-03
Z-1320-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-04-03

Product code FMF

K875196Class IIDisposable Coronary Control Syringe 12CcMerit Medical Systems, Inc. / cleared 1988-02-11

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)