Merit Medical recalls Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F (REF 4992209) 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: Peritoneal Drainage Catheter Insertion Tray 15.5F models with certain lot numbers because the valve might not open properly, which could prevent fluid drainage. This is a safety issue for medical procedures involving peritoneal dialysis.
The valve assemblies in the tray may not open correctly, which could prevent proper drainage of fluid from the peritoneal cavity. This risk is specific to medical procedures where fluid drainage is critical, such as peritoneal dialysis.
Healthcare providers using the Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F for peritoneal dialysis procedures are most at risk. Patients receiving this device for medical treatment may also be affected.
Check the lot numbers: I2533611, I2546597, I2559292, I2548163, and I2578001. The product has a UDI-DI code of 00884450394908 and is labeled as Sterile EO, Rx Only.
Verify if your tray has any of the lot numbers: I2533611, I2546597, I2559292, I2548163, or I2578001.
The recall indicates a potential issue with valve function, but the product is generally safe unless the valve fails to open, which could prevent fluid drainage during medical procedures.
Check the lot numbers on your tray. If it matches the listed lots, contact Merit Medical Systems for further instructions.
Look for the lot numbers I2533611, I2546597, I2559292, I2548163, or I2578001 on the product label. The UDI-DI code 00884450394908 also identifies affected units.
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-1911-2023 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1911-2023 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.