The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1920-2023·Announced 2023-06-21

Aspira Drainage Catheter Insertion Tray valve assembly may fail to open

Merit Medical Systems is recalling certain Aspira Drainage Catheter Insertion Trays (Model 15.5F) due to a potential valve assembly defect that could prevent fluid drainage. No injuries have been 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: FDA Class II recall for a potential medical device malfunction where valve assemblies may not open, preventing proper fluid drainage. No illnesses or injuries have been reported, indicating a theoretical rather than confirmed risk.

Plain-English summary

Merit Medical Systems, Inc. is recalling the Aspira Drainage Catheter Insertion Tray (15.5F, REF: ASP-15-5) due to a potential valve assembly defect. The valve assemblies may not open properly, which could prevent fluid from draining as intended.

The recalled product was distributed nationwide in the United States, as well as in France, the United Kingdom, and Mexico. The affected lot number is I2559306, with UDI-DI 00884450488492. This recall involves 2 units.

Healthcare providers and facilities using this product should immediately stop using units from the affected lot and contact Merit Medical Systems for further guidance. Patients and providers should verify the lot number of any units in use and seek appropriate alternatives to ensure continued safe patient care.

The recalled product

Product
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Drainage Catheter
Hazard
Affected units
2

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 # I2559306
  • UDI-DI: 00884450488492

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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