Aspira Pleural Drainage Catheter Insertion Tray recalled for valve assembly malfunction
Merit Medical Systems is recalling the Aspira Pleural Drainage Catheter Insertion Tray because valve assemblies may not open, preventing proper 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 an FDA Class II recall involving a medical device with a functional failure risk. No hospitalizations or injuries have been reported. The hazard—valve assembly failure preventing fluid drainage—qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric for High severity.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Aspira Pleural Drainage Catheter Insertion Tray (Reference 4992506, Version A, UDI-DI 00884450398173). The recall involves 156 units distributed nationwide in the United States, Puerto Rico, and to France, the United Kingdom, and Mexico.
The catheter insertion tray may have valve assemblies that fail to open properly. When valve assemblies do not open, fluid cannot drain as intended, potentially compromising the device's critical drainage function.
Affected lot numbers are I2632727, I2558682, I2623159, and I2618461. Healthcare facilities and medical professionals who have received affected units should discontinue use and contact Merit Medical Systems for instructions on returns or replacement.
The recalled product
- Product
- Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device
- 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 (5)
- Lot # I2632727
- I2558682
- I2623159
- I2618461
- UDI-DI: 00884450398173
Distribution
Distributed nationwide across the United States.
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