The Recall Desk
HighFDA (Devices)·Z-1918-2023·Announced 2023-06-21

Aspira Drainage Catheter Tray Recalled for Potential Valve Malfunction

Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly failure that may 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 medical device with a potential valve malfunction that could prevent proper fluid drainage. No hospitalizations, injuries, or deaths reported. This is a risk-of-harm product where injury has not yet been documented.

Plain-English summary

Merit Medical Systems, Inc. is recalling Aspira Drainage Catheter Insertion Tray 15.5F (REF: ASP-11-5) due to a potential issue with valve assemblies. The valve may fail to open properly, which could prevent fluid from draining as intended.

If the valve assembly does not open, the catheter cannot drain fluid correctly, which could impact patient care. Affected units include lot number I2578012.

The recall affects 7 units distributed across all U.S. states, Puerto Rico, France, the United Kingdom, and Mexico. No injuries or adverse events have been reported to date.

Affected healthcare providers and patients should discontinue use of the product and contact Merit Medical Systems for replacement or return instructions.

The recalled product

Product
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Drainage Catheter
Hazard
  • valve-malfunction
  • drainage-blockage

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 # I2578012
  • UDI-DI: 00884450488539

Distribution

Distributed nationwide across the United States.

Related recalls

Same category