Merit Medical recalls Aspira Drainage Catheter Insertion Tray 15.5F (EU only) due to 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 Aspira Drainage Catheter Insertion Tray 15.5F models sold in Europe. The recall is because valve assemblies might not open properly, which could cause fluid buildup and potential infection risks.
The valve assemblies in the tray may not open correctly, preventing fluid from draining. This could lead to fluid buildup, increasing the risk of infection or complications during medical procedures.
Healthcare professionals using the Aspira Drainage Catheter Insertion Tray 15.5F in Europe are likely affected. Patients receiving drainage procedures with this tray may be at risk if the valve fails.
Check for the model number 15.5F, reference code ASP-11-5, and lot number I2578012. The product is only sold in Europe and has a unique device identifier (UDI-DI) 00884450488539.
Verify the model number, reference code, lot number, and UDI-DI code on the product label.
The recall indicates a potential valve failure that could prevent fluid drainage, so it is not recommended for use until the remedy is applied.
The recall does not specify a remedy, so contact Merit Medical directly for guidance on next steps.
No, the product is only distributed in Europe as stated in the recall.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1918-2023 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-1918-2023 from Merit Medical. 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.
