Aspira Peritoneal Drainage Catheter Insertion Tray valve malfunction
Merit Medical's Aspira Peritoneal Drainage Catheter Insertion Tray valve assemblies may fail to open, preventing fluid drainage. 175 units distributed nationwide and internationally are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where valve failure could prevent necessary peritoneal fluid drainage. The source describes only a potential hazard with no reported illnesses, injuries, or deaths, placing this at High (3) per the rubric: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F (REF 4992208, Version A) because valve assemblies in the device may not open properly, which could prevent necessary fluid drainage.
Affected units include 175 trays with lot numbers I2538438, I2614180, and I2623234, distributed nationwide throughout all U.S. states, as well as to France, United Kingdom, and Mexico.
The recalled product
- Product
- Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- valve-malfunction
- device-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # I2538438
- I2614180
- I2623234/ UDI: 00884450394892
Distribution
Distributed nationwide across the United States.
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