Z-0027-2020Class II

Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01)...

Name: Z-0027-2020 Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01)...
Creator: Merit Medical Systems, Inc.
Published: 2018-10-26
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2018-10-26 / Terminated / root cause: labeling and UDI

FDA source

Merit Medical Systems, Inc. began a recall of Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580 on 2018-10-26. FDA classified it as Class II and gives the reason as "Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)". 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-0027-2020
Classification: Class II
Status: Terminated
Initiated: 2018-10-26
Posted: 2019-10-01
Terminated: 2020-06-12
Recalling firm: Merit Medical Systems, Inc.
Product: Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Product code: OES Cardiac Catheterization Kit
Reason for recall: Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 10/26/2018, Merit customer service representative placed telephone calls to consignees to inform them of the latex contained in the kits/trays. On 10/29/2018, the firm sent an "Urgent Product recall Notice" to all affected consignees via FedEx. The recall notification informed customers of the following: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan and email the completed CRF to [email protected] within 10 business days. 5. Please immediately return all affected lots in your possession to Merit, per the instructions found in the CRF. 6. If you have any questions concerning this communication, please contact Merit Customer service at (801) 208-4381 or by email at [email protected].
Quantity in commerce: 24 kits
Distribution: U.S.: VA, IL
Product codes and lots: Catalog # K12T-10167, Lot # K12T-10167, Use By: 2018-11-05

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0027-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0026-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-01
Z-0027-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-01

Product code OES

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)