Merit Medical recalls Aspira Drainage Catheter Insertion Tray 15.5F (EU only) 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 Aspira Drainage Catheter Insertion Tray 15.:5F models sold in Europe because valve assemblies might not open, preventing fluid drainage. This could lead to improper drainage and potential complications for patients using the device.
The valve assemblies in the tray might not open properly, which could prevent fluid from draining. This could lead to buildup of fluid and potential complications if the device is used without proper drainage.
Healthcare professionals in Europe who use the Aspira Drainage Catheter Insertion Tray 15.5F (model ASP-15-5) are most at risk. Patients using the device for drainage procedures may also be affected.
Check for the model number ASP-15-5 on the tray, and look for lot number I2559306 or UDI-DI code 00884450488492. The product is only distributed in Europe.
Identify the model number (ASP-15-5) and lot number (I2559306) or UDI-DI code (00884450488492) on the tray.
The recall states there is a potential that valve assemblies will not open, preventing fluid drainage. The product may not be safe for use as intended.
Check for model number ASP-15-5, lot number I2559306, or UDI-DI code 00884450488492. The product is only distributed in Europe.
The recall does not specify a remedy, so contact Merit Medical Systems for further instructions.
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-1920-2023 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1920-2023 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.
