Merit Medical recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F (REF: 499:2509) 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 Pleural Drainage Catheter Insertion Trays because valve assemblies might not open, which could prevent fluid drainage. This is a medical device used during pleural drainage procedures and could lead to complications if fluid builds up.
The valve assemblies in the tray may not open properly, which could prevent fluid from draining from the pleural space. This might cause fluid buildup and potential complications during medical procedures.
Healthcare professionals using the Aspira Pleural Drainage Catheter Insertion Tray for pleural drainage procedures are most at risk. Patients receiving this device during medical treatment may also be affected.
Check for the product name 'Aspira Pleural Drainage Catheter Insertion Tray 15.5F', reference number 4992509, version A, and sterile EO packaging. Lot numbers include I2614171, I2559314, I2546596, I2614170, I2538442, I2564679, I2548181, I2623231.
Identify the product name, reference number, version, and lot numbers to confirm if your tray is affected.
The recall states there is a potential that valve assemblies may not open, preventing fluid drainage. This could lead to complications, so affected units should be checked.
Check for the product name 'Aspira Pleural Drainage Catheter Insertion Tray 15.5F', reference number 4992509, version A, and sterile EO packaging. Lot numbers include I2614171, I2559314, I2546596, I2614170, I2538442, I2564679, I2548181, I2623231.
The recall does not specify a remedy, so check with Merit Medical Systems for further instructions if you have the affected product.
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-1915-2023 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1915-2023 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.
