The Recall Desk
HighFDA (Devices)·Z-1917-2023·Announced 2023-06-21

Aspira Drainage Catheter Insertion Tray May Have Non-Opening Valve

Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly malfunction that could prevent 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 a medical device recall for a high-risk product where malfunction could cause serious patient harm. While no injuries have been reported and the hazard is stated as potential rather than confirmed, a drainage catheter failure represents a significant risk-of-harm where injury has not yet been reported, placing this in the High severity category.

Plain-English summary

Merit Medical Systems, Inc. is recalling the Aspira Drainage Catheter Insertion Tray 15.5F (REF: ASP-11) due to a potential defect in the valve assembly.

The valve assemblies in affected units may fail to open properly, which could prevent fluid drainage through the catheter.

This recall affects 17 units distributed in the United States, France, United Kingdom, and Mexico.

Healthcare providers and patients who have this product should stop using it and contact Merit Medical Systems or the FDA for further instructions.

The recalled product

Product
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution 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 (2)

  • Lot # I2587050
  • UDI-DI: 00884450488447

Distribution

Distributed nationwide across the United States.

Related recalls

Same category