Merit Medical recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F (REF 4992507) 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 Aspir: Pleural Drainage Catheter Insertion Tray 15.5F models that may have valve assemblies that don't open properly, preventing fluid drainage. This could lead to fluid buildup and infection risks if not addressed.
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.
Healthcare professionals using the Aspira Pleural Drainage Catheter Insertion Tray 15.5F for medical procedures are most at risk. Patients receiving drainage treatments may also be affected if the device fails.
Check for the model number 15.5F, reference number 4992507, version A, and sterile EO packaging. Affected units have specific lot numbers: I2548172, I2568218, I2553914, I2614174, I2638785, I2559299.
Look for lot numbers I2548172, I2568218, I2553914, I2614174, I2638785, or I2559299 on the packaging.
The recall indicates a potential issue with valve assemblies that may prevent fluid drainage, so it's not safe to use without checking the lot numbers.
Check for the model number 15.5F, reference number 4992507, version A, and sterile EO packaging with one of the specific lot numbers listed.
The recall does not specify a remedy, so contact Merit Medical Systems for guidance on next steps.
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-1913-2023 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1913-2023 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.
