Merit Medical recalls Aspira Drainage Catheter Insertion Tray 15.5F (EU) 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 the valve might not open properly, which could cause fluid buildup. This is a medical device used during procedures, so it's important to stop using affected units to prevent complications.
The valve in the tray may not open correctly, which could prevent fluid from draining properly. This might lead to fluid buildup in the patient's body, potentially causing complications during medical procedures.
Healthcare professionals using the Aspira Drainage Catheter Insertion Tray 15.5F in Europe are most at risk. Patients receiving this device during procedures may also be affected if the valve fails.
Check for the model number 15.5F, reference code ASP-11, and sterile EO labeling. Affected units were sold in Europe with lot number I2587050 and UDI-DI code 00884450488447.
Look for the model number 15.5F, reference code ASP-11, and sterile EO labeling on the tray.
The recall states there is a potential that valve assemblies may not open, which could prevent fluid drainage. Affected units should be checked and stopped if they have the specific lot number or UDI-DI code.
Check for the model number 15.5F, reference code ASP-11, and sterile EO labeling. Affected units have lot number I2587050 and UDI-DI code 00884450488447.
The recall does not specify a remedy, so check the product details and contact Merit Medical Systems if you have the specific lot number or UDI-DI code.
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-1917-2023 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1917-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
