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.

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

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.