Z-0002-2017Class II

Merit Inflation Syringe Kit. Catalog Number KOS-02857

Name: Z-0002-2017 Merit Inflation Syringe Kit. Catalog Number KOS-02857
Creator: Merit Medical Systems, Inc.
Published: 2016-08-25
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2016-08-25 / Terminated / root cause: labeling and UDI

FDA source

Merit Medical Systems, Inc. began a recall of Merit Inflation Syringe Kit. Catalog Number KOS-02857 on 2016-08-25. FDA classified it as Class II and gives the reason as "Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information". 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-0002-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-25
Posted: 2016-10-03
Terminated: 2016-12-01
Recalling firm: Merit Medical Systems, Inc.
Product: Merit Inflation Syringe Kit. Catalog Number KOS-02857
Product code: MAV Syringe, Balloon Inflation
Reason for recall: Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Merit Medical Inc. notified all affected customers on August 25, 2016, via verbal and written notification to return the affected units. The returned units will be re-labeled. For further questions, please call (801) 316-3690.
Quantity in commerce: 1,297 total units
Distribution: One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.
Product codes and lots: Lot Numbers: H959038, H970334, H984351.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0002-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0002-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-03

Product code MAV

K122321Class IIBasixconpak Analog Inflation SyringeMerit Medical Ireland, Ltd. / cleared 2012-12-19

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)