Aspira Peritoneal Drainage Catheter Insertion Tray Valve Malfunction Recall
Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays due to a potential valve assembly malfunction that could prevent fluid drainage. No injuries have been reported.
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: FDA Class II medical device with a potential valve malfunction that could prevent proper fluid drainage. No reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Merit Medical Systems, Inc. is recalling Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F (REF 4992206 Version A). This is a sterile, prescription-only medical device used for peritoneal drainage procedures.
The recall was issued due to a potential malfunction in which valve assemblies will not open, preventing fluid from draining.
The recalled product (Lot I2605742, UDI-DI 00884450398166) was distributed nationwide across all U.S. states, Puerto Rico, and internationally to France, the United Kingdom, and Mexico.
Healthcare providers and facilities should contact Merit Medical Systems, Inc. or the FDA for guidance regarding this recall.
The recalled product
- Product
- Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- valve-malfunction
- drainage-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 (2)
- Lot # I2605742
- UDI-DI: 00884450398166
Distribution
Distributed nationwide across the United States.
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