Aspira Drainage Catheter Insertion Tray recalled due to valve malfunction
Merit Medical Systems is recalling Aspira Drainage Catheter Insertion Tray 15.5F due to potential valve assembly failure that may prevent fluid drainage. No injuries 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: This is a risk-of-harm medical device where functional failure (non-opening valve preventing fluid drainage) has not resulted in reported illnesses or injuries. FDA Class II classification with no reported adverse events supports a score of 3 per the rubric.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Aspira Drainage Catheter Insertion Tray 15.5F (REF: ASP-15, Lot #I2587055) because valve assemblies in affected units may fail to open properly, potentially preventing the drainage of fluids as intended.
Approximately 40 units were distributed worldwide, including across all U.S. states and territories, as well as France, the United Kingdom, and Mexico. The product carries UDI-DI: 00884450488416.
If you have received or used this product, contact Merit Medical Systems, Inc. or the FDA for instructions on replacement or return. No injuries or adverse events related to this defect have been reported to date.
The recalled product
- Product
- Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- valve-failure
- drainage-obstruction
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 # I2587055
- UDI-DI: 00884450488416
Distribution
Distributed nationwide across the United States.
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