Aspira Drainage Catheter Insertion Tray valve assembly may fail to open
Merit Medical Systems is recalling certain Aspira Drainage Catheter Insertion Trays (Model 15.5F) due to a potential valve assembly defect 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 recall for a potential medical device malfunction where valve assemblies may not open, preventing proper fluid drainage. No illnesses or injuries have been reported, indicating a theoretical rather than confirmed risk.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Aspira Drainage Catheter Insertion Tray (15.5F, REF: ASP-15-5) due to a potential valve assembly defect. The valve assemblies may not open properly, which could prevent fluid from draining as intended.
The recalled product was distributed nationwide in the United States, as well as in France, the United Kingdom, and Mexico. The affected lot number is I2559306, with UDI-DI 00884450488492. This recall involves 2 units.
Healthcare providers and facilities using this product should immediately stop using units from the affected lot and contact Merit Medical Systems for further guidance. Patients and providers should verify the lot number of any units in use and seek appropriate alternatives to ensure continued safe patient care.
The recalled product
- Product
- Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution 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 # I2559306
- UDI-DI: 00884450488492
Distribution
Distributed nationwide across the United States.
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