Aspira Valve Repair Kit recall
Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
Why was Aspira Valve Repair Kit recalled?
There is a potential that valve assemblies will not open. preventing fluid from draining.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # I2604364, I2604393, I2587036, I2564649, I2558681, I2604394, I2609065, I2623156, I2577984; UDI-DI: 00884450394960
- Product
- Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 2559 units
- Distribution
- 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.
- Recall date
- June 21, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)