The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1908-2023·Announced 2023-06-21

Aspira Peritoneal Drainage Catheter Insertion Tray Valve Malfunction Recall

Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays due to a potential valve assembly malfunction 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 medical device with a potential valve malfunction that could prevent proper fluid drainage. No reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injury score 3 (High).

Plain-English summary

Merit Medical Systems, Inc. is recalling Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F (REF 4992206 Version A). This is a sterile, prescription-only medical device used for peritoneal drainage procedures.

The recall was issued due to a potential malfunction in which valve assemblies will not open, preventing fluid from draining.

The recalled product (Lot I2605742, UDI-DI 00884450398166) was distributed nationwide across all U.S. states, Puerto Rico, and internationally to France, the United Kingdom, and Mexico.

Healthcare providers and facilities should contact Merit Medical Systems, Inc. or the FDA for guidance regarding this recall.

The recalled product

Product
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Peritoneal Drainage
Hazard
Affected units
5

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 # I2605742
  • UDI-DI: 00884450398166

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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