Merit Medical recalls Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F (REF 49922: Version A) 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 Peritoneal Drainage Catheter Insertion Trays because valve assemblies might not open, which could prevent proper fluid drainage. This could lead to complications for patients needing peritoneal dialysis.
The valve assemblies in the tray may not open properly, which could prevent fluid from draining from the peritoneal cavity. This risk is specific to peritoneal dialysis patients who rely on the device to remove waste fluid from their bodies.
Healthcare providers using the Aspira Peritoneal Drainage Catheter Insertion Tray for peritoneal dialysis patients are most at risk. Patients with kidney failure requiring dialysis may be affected if they use this device.
Check for the model number 15.5F, REF 4992207 Version A, Sterile EO, Rx Only. Lot numbers starting with I2605742 and UDI-DI code 00884450398166 indicate affected units.
Verify the model number, lot number, and UDI-DI code to confirm if your unit is affected.
The recall states there is a potential that valve assemblies will not open, preventing fluid drainage. This could lead to complications for patients needing peritoneal dialysis, but the risk is not immediate.
Affected units have model number 15.5F, REF 4992207 Version A, Sterile EO, Rx Only, lot number I2605742, and UDI-DI code 00884450398166.
The recall record does not specify a remedy, so contact Merit Medical directly for guidance.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1909-2023 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-1909-2023 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.