Merit Medical recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F (REF 4992508) 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 potential complications 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, potentially causing complications such as infection or increased pressure.
Healthcare professionals using the Aspira Pleural Drainage Catheter Insertion Tray 15.5F for medical procedures are most at risk. Patients receiving this device may also be affected if the valve fails.
Check for the product name 'Aspira Pleural Drainage Catheter Insertion Tray 15.5F' with reference number 4992508, version A, and sterile EO packaging. Affected units have specific lot numbers: I2559297, I2564678, I2553915, I2614173, I2568219.
Verify the product name, reference number, version, and lot numbers to confirm if your item is affected.
The recall indicates a potential issue with valve function, but the product may still be safe for use if the valve opens properly. Affected units should be checked for the specific lot numbers listed.
The recall does not specify a remedy, so contact Merit Medical Systems for guidance on whether to stop using or return the product.
Check for the product name 'Aspira Pleural Drainage Catheter Insertion Tray 15.5F' with reference number 4992508, version A, and sterile EO packaging. Affected units have specific lot numbers: I2559297, I2564678, I2553915, I2614173, I2568219.
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-1914-2023 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1914-2023 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.
