Z-1916-2023 Class II Ongoing
FDA device recall Z-1916-2023 was initiated by Merit Medical Systems, Inc. on April 22, 2023 and is designated Class II. Reason for recall: There is a potential that valve assemblies will not open. preventing fluid from draining. The recall status is ongoing. Affected quantity: 2559 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2023
- Initiation Date
- April 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2559 units
Product Description
Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
Reason for Recall
There is a potential that valve assemblies will not open. preventing fluid from draining.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.
Code Information
Lot # I2604364, I2604393, I2587036, I2564649, I2558681, I2604394, I2609065, I2623156, I2577984; UDI-DI: 00884450394960