The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1911-2023·Announced 2023-06-21

Merit Medical Peritoneal Drainage Catheter Insertion Tray Recalled for Valve Failure

Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays because valve assemblies may fail to open, potentially preventing proper fluid drainage in affected lots.

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 the valve assembly may fail to open, preventing necessary fluid drainage in a peritoneal catheter procedure. No illnesses or injuries have been reported, and the hazard is stated as a potential defect rather than confirmed cases, limiting the score to 3 per the rubric criterion for theoretical hazards without reported injury.

Plain-English summary

Merit Medical Systems, Inc. is recalling the Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F (Reference Number 4992209, Version A, sterile, Rx only). The recall involves 670 units distributed worldwide.

The affected product has been distributed across the United States, Puerto Rico, France, the United Kingdom, and Mexico. The specific lot numbers involved in this recall are I2533611, I2546597, I2559292, I2548163, and I2578001. The UDI-DI is 00884450394908.

The catheter insertion tray is being recalled due to a potential defect in the valve assemblies. These valve assemblies may fail to open properly, which could prevent fluid from draining as intended. This is a Class II medical device recall.

Healthcare facilities, providers, and patients with affected trays should contact Merit Medical Systems, Inc. or the FDA for information regarding this recall and any available replacements or corrective actions.

The recalled product

Product
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Peritoneal Drainage Catheter
Hazard
Affected units
670

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 (5)

  • Lot # I2533611
  • I2546597
  • I2559292
  • I2548163 & I2578001
  • UDI-DI: 00884450394908

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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