The Recall Desk
Agency classClass IIOur severity: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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units
17

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.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 13 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

See all →

Same hazard · valve malfunction

See all →

Similar recalls