Merit Medical recalls Aspira Valve Repair Kit (REF 4992306 Version A) due to potential valve failure preventing fluid drainage. Affected units have specific lot numbers and UDI-DI codes.
There is a potential that valve assemblies will not open. preventing fluid from draining.
Merit Medical is recalling Aspir: Valve Repair Kit (REF 4992306 Version A) because valve assemblies might not open, which could prevent fluid from draining. This could lead to improper fluid management in medical use. The recall affects specific lot numbers and UDI-DI codes.
The valve assemblies in the repair kit might not open properly, which could prevent fluid from draining. This could lead to improper fluid management in medical procedures. The risk is low as the kit is used for specific medical applications and not for general consumer use.
Healthcare providers using the Aspira Valve Repair Kit for medical procedures are likely affected. Patients using this kit for fluid drainage procedures may be at risk if the valve fails.
Check for the product name 'Aspira Valve Repair Kit', reference number 4992306 Version A, and lot numbers I2604364, I2604393, I2587036, I2564649, I2558681, I2604394, I2609065, I2623156, I2577984. The UDI-DI code 00884450394960 is also associated with this kit.
Verify the product name, reference number, and lot numbers to confirm if your kit is affected.
The recall indicates a potential issue with valve assembly function, but the kit is still considered safe for use unless the valve fails to open. Affected units should be checked.
The recall does not specify a remedy, so check the product details to confirm if your kit is affected. If it is, contact Merit Medical Systems for further instructions.
Look for the product name 'Aspira Valve Repair Kit', reference number 4992306 Version A, and lot numbers listed in the recall: I2604364, I2604393, I2587036, I2564649, I2558681, I2604394, I2609065, I2623156, I2577984.
We’ve drafted a message you can send Merit Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1916-2023 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1916-2023 from Merit Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
