The Recall Desk
HighFDA (Devices)·Z-1910-2023·Announced 2023-06-21

Aspira Peritoneal Drainage Catheter Insertion Tray valve malfunction

Merit Medical's Aspira Peritoneal Drainage Catheter Insertion Tray valve assemblies may fail to open, preventing fluid drainage. 175 units distributed nationwide and internationally are affected.

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 valve failure could prevent necessary peritoneal fluid drainage. The source describes only a potential hazard with no reported illnesses, injuries, or deaths, placing this at High (3) per the rubric: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Merit Medical Systems, Inc. is recalling the Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F (REF 4992208, Version A) because valve assemblies in the device may not open properly, which could prevent necessary fluid drainage.

Affected units include 175 trays with lot numbers I2538438, I2614180, and I2623234, distributed nationwide throughout all U.S. states, as well as to France, United Kingdom, and Mexico.

The recalled product

Product
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Peritoneal Drainage Catheter
Hazard
Affected units
175

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 (3)

  • Lot # I2538438
  • I2614180
  • I2623234/ UDI: 00884450394892

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 →

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

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Same hazard · valve malfunction

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