Aspira Pleural Drainage Catheter trays recalled for valve failure
Merit Medical Systems recalls Aspira Pleural Drainage Catheter Insertion Trays because valve assemblies may not open, preventing fluid drainage. The recall affects 436 units distributed nationwide and internationally.
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 of a medical device with a significant functional defect (valve failure preventing fluid drainage). No illnesses or injuries are reported in the source text, so the score is capped at High per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Merit Medical Systems, Inc. is recalling Aspira Pleural Drainage Catheter Insertion Tray 15.5F (REF 4992508, Version A, Sterile EO). The device is a single-use insertion tray designed for placement of a pleural drainage catheter.
The recall was issued because valve assemblies in the insertion trays may not open properly, which could prevent fluid from draining from the pleural space as intended.
Affected product lots are I2559297, I2564678, I2553915, I2614173, and I2568219. A total of 436 units were distributed worldwide, including nationwide distribution throughout the United States, Puerto Rico, France, United Kingdom, and Mexico.
The recalled product
- Product
- Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx 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 (6)
- Lot # I2559297
- I2564678
- I2553915
- I2614173
- I2568219
- UDI-DI: 00884450394939
Distribution
Distributed nationwide across the United States.
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