FDA Recalls Aspira Peritoneal Drainage Catheter Insertion Tray for Valve Failure
Merit Medical Systems recalls Aspira Peritoneal Drainage Catheter Insertion Tray due to a potential valve failure that could prevent necessary fluid drainage.
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 scored as High (3) per the rubric's criterion for 'risk-of-harm products where injury has not yet been reported.' The FDA classification is Class II, but no hospitalizations, illnesses, or injuries are mentioned in the source, and the hazard is described as 'potential' rather than confirmed.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F (Reference 4992207, Version A) due to a potential valve assembly defect. The affected lot is I2605742, and 27 units are involved.
The valve assemblies in the affected units have the potential to not open properly, which could prevent fluid from draining as intended. No illnesses or injuries have been reported related to this issue.
The recalled devices were distributed worldwide, including throughout the United States (all 50 states, Washington D.C., and Puerto Rico) and to France, the United Kingdom, and Mexico. Healthcare facilities that have received these devices should verify whether they have the affected lot number.
The recalled product
- Product
- Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- device-malfunction
- valve-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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