The Recall Desk
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.

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 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
  • 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 (2)

  • Lot # I2587055
  • UDI-DI: 00884450488416

Distribution

Distributed nationwide across the United States.

Related recalls

Same category