The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1919-2023·Announced 2023-06-21

Aspira Drainage Catheter Insertion Tray recalled due to valve malfunction

Merit Medical Systems is recalling Aspira Drainage Catheter Insertion Tray 15.5F due to potential valve assembly failure that may prevent fluid drainage. No injuries reported.

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 risk-of-harm medical device where functional failure (non-opening valve preventing fluid drainage) has not resulted in reported illnesses or injuries. FDA Class II classification with no reported adverse events supports a score of 3 per the rubric.

Plain-English summary

Merit Medical Systems, Inc. is recalling the Aspira Drainage Catheter Insertion Tray 15.5F (REF: ASP-15, Lot #I2587055) because valve assemblies in affected units may fail to open properly, potentially preventing the drainage of fluids as intended.

Approximately 40 units were distributed worldwide, including across all U.S. states and territories, as well as France, the United Kingdom, and Mexico. The product carries UDI-DI: 00884450488416.

If you have received or used this product, contact Merit Medical Systems, Inc. or the FDA for instructions on replacement or return. No injuries or adverse events related to this defect have been reported to date.

The recalled product

Product
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Catheter / Drainage Device
Hazard
Affected units
40

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 # I2587055
  • UDI-DI: 00884450488416

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 →

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