The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1914-2023·Announced 2023-06-21

Aspira Pleural Drainage Catheter trays recalled for valve failure

Merit Medical Systems recalls Aspira Pleural Drainage Catheter Insertion Trays because valve assemblies may not open, preventing fluid drainage. The recall affects 436 units distributed nationwide and internationally.

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 an FDA Class II recall of a medical device with a significant functional defect (valve failure preventing fluid drainage). No illnesses or injuries are reported in the source text, so the score is capped at High per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Merit Medical Systems, Inc. is recalling Aspira Pleural Drainage Catheter Insertion Tray 15.5F (REF 4992508, Version A, Sterile EO). The device is a single-use insertion tray designed for placement of a pleural drainage catheter.

The recall was issued because valve assemblies in the insertion trays may not open properly, which could prevent fluid from draining from the pleural space as intended.

Affected product lots are I2559297, I2564678, I2553915, I2614173, and I2568219. A total of 436 units were distributed worldwide, including nationwide distribution throughout the United States, Puerto Rico, France, United Kingdom, and Mexico.

The recalled product

Product
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Pleural Drainage
Hazard
Affected units
436

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 (6)

  • Lot # I2559297
  • I2564678
  • I2553915
  • I2614173
  • I2568219
  • UDI-DI: 00884450394939

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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