Merit Medical recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F (REF 4992506) due to potential valve failure preventing fluid drainage. Affected units have specific lot numbers and sterile packaging.
There is a potential that valve assemblies will not open. preventing fluid from draining.
Merit Medical is recalling Aspir: Pleural Drainage Catheter Insertion Trays that may have valve assemblies that don't open properly, preventing fluid drainage. This could lead to fluid buildup and infection risks if the device isn't used correctly.
The valve assemblies in the tray may not open correctly, which can prevent fluid from draining properly. This could lead to fluid buildup in the pleural space, increasing the risk of infection or complications if the device is used without proper drainage.
Healthcare professionals using the Aspira Pleural Drainage Catheter Insertion Tray for medical procedures are most at risk. Patients receiving this device during surgery or medical treatment may also be affected.
Check for the product name 'Aspira Pleural Drainage Catheter Insertion Tray 15.5F', reference number 4992506, version A, and sterile packaging. Affected units have specific lot numbers: I2632727, I2558682, I2623159, or I2618461.
Look for the product name, reference number 4992506, version A, and sterile packaging on the tray.
The recall indicates a potential issue with valve function, but the product is generally safe if used correctly. Affected units should be checked for the specific lot numbers listed.
The recall does not specify a remedy, so contact Merit Medical directly for guidance on whether your unit is affected.
Check for the product name 'Aspira Pleural Drainage Catheter Insertion Tray 15.5F', reference number 4992506, version A, and sterile packaging. Affected units have specific lot numbers: I2632727, I2558682, I2623159, or I2618461.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1912-2023 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-1912-2023 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.