The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1909-2023·Announced 2023-06-21

FDA Recalls Aspira Peritoneal Drainage Catheter Insertion Tray for Valve Failure

Merit Medical Systems recalls Aspira Peritoneal Drainage Catheter Insertion Tray due to a potential valve failure that could prevent necessary 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 scored as High (3) per the rubric's criterion for 'risk-of-harm products where injury has not yet been reported.' The FDA classification is Class II, but no hospitalizations, illnesses, or injuries are mentioned in the source, and the hazard is described as 'potential' rather than confirmed.

Plain-English summary

Merit Medical Systems, Inc. is recalling the Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F (Reference 4992207, Version A) due to a potential valve assembly defect. The affected lot is I2605742, and 27 units are involved.

The valve assemblies in the affected units have the potential to not open properly, which could prevent fluid from draining as intended. No illnesses or injuries have been reported related to this issue.

The recalled devices were distributed worldwide, including throughout the United States (all 50 states, Washington D.C., and Puerto Rico) and to France, the United Kingdom, and Mexico. Healthcare facilities that have received these devices should verify whether they have the affected lot number.

The recalled product

Product
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Peritoneal Drainage Catheter
Hazard
Affected units
27

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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