Z-0062-2025Class II

Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The...

Name: Z-0062-2025 Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The...
Creator: Merit Medical Systems, Inc.
Published: 2024-08-30
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2024-08-30 / Open, Classified / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and... on 2024-08-30. FDA classified it as Class II and gives the reason as "Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0062-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-30
Posted: 2024-10-11
Recalling firm: Merit Medical Systems, Inc.
Product: Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 08/30/2024, the firm email and/or UPS overnight delivery an "URGENT MEDICAL DEVICE RECALL NOTICE" informing customers that specific lots of MONARCH Inflation Devices due to a packaging defect, there may be a small hole in the Tyvek sterile barrier of the device packaging. Use of the affected product may result in exposure to pathogens/pyrogens which could lead to infection. Customer are instructed to: 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 Customer Service at [email protected] within 7 calendar days. All affected product shipped to you must be accounted for on the CRF. 5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF. For questions - contact your Merit Sales Representative or Merit Customer Service via email at [email protected] or via phone at +1 800 356 3748 | Hours: 6 am to 6 pm MST | Mon-Fri.
Quantity in commerce: 432 devices
Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.
Product codes and lots: Catalog Number: K05T-02159 UDI-DI code: 00884450140840 Lot Number: T2417859 T2434208 T2509792 T2549931 T2561788 T2625814 T2675576 T2762716 T2801089 T2893877

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0062-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0057-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11
Z-0058-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11
Z-0059-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11
Z-0060-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11
Z-0061-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11
Z-0062-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11

Product code DXT

K011811Class IIMonarch Inflation Syringe; Universal Fluid Dispensing SyringeMerit Medical Systems, Inc. / cleared 2001-08-22

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)