Merit Medical recalls EU-only Aspira Drainage Catheter Insertion Tray 15.5F (REF ASP-15) 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 a specific drainage catheter insertion tray for EU markets because its valve may not open properly, preventing fluid drainage. This could lead to complications if fluid builds up inside the patient.
The valve assemblies in the tray may not open correctly, which can prevent fluid from draining properly. This could cause fluid buildup inside the patient, potentially leading to complications during medical procedures.
Healthcare professionals in EU countries who use the Aspira Drainage Catheter Insertion Tray 15.5F (REF ASP-15) are most at risk. Patients using this device for drainage procedures may experience complications if fluid drainage is blocked.
Check for the model number ASP-15 on the tray, and look for the lot number I2587055 or UDI-DI code 00884450488416. This product is only distributed in the European Union.
Inspect the tray to see if the valve assemblies open properly to allow fluid drainage.
The recall states there is a potential that valve assemblies will not open, preventing fluid drainage. This could lead to complications, so it is not safe to use without checking.
Look for the model number ASP-15, lot number I2587055, or UDI-DI code 00884450488416. This product is only distributed in the European Union.
The recall does not specify a remedy, so check if the valve opens properly. If it does not, contact Merit Medical Systems for further guidance.
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-1919-2023 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1919-2023 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.