The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1915-2023·Announced 2023-06-21

Aspira Pleural Drainage Catheter Insertion Tray recalled due to valve failure

Merit Medical Systems recalls the Aspira Pleural Drainage Catheter Insertion Tray due to a potential valve failure that could prevent fluid drainage. The recall affects approximately 1054 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: FDA Class II medical device recall with functional defect (valve failure preventing drainage) but no reported injuries, illnesses, or hospitalizations. Qualifies as risk-of-harm product without reported injury per rubric criterion.

Plain-English summary

Merit Medical Systems, Inc. has recalled the Aspira Pleural Drainage Catheter Insertion Tray 15.5F (REF: 4992509, Version A, Sterile EO) due to a potential defect in the valve assembly.

The recalled device carries a risk that valve assemblies will not open properly, which could prevent fluid from draining as intended. This is a Class II recall issued by the FDA.

The recall affects approximately 1054 units with lot numbers I2614171, I2559314, I2546596, I2614170, I2538442, I2564679, I2548181, and I2623231. The product was distributed nationwide across all US states, Puerto Rico, and internationally to France, the United Kingdom, and Mexico. This is a prescription-only medical device.

Healthcare providers and facilities that have received this product should discontinue use and contact the manufacturer for instructions on device replacement or proper handling. Patients or healthcare professionals who have used these units and have concerns should consult with their healthcare provider.

The recalled product

Product
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Drainage Equipment
Hazard
Affected units
1,054

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 (9)

  • Lot # I2614171
  • I2559314
  • I2546596
  • I2614170
  • I2538442
  • I2564679
  • I2548181
  • I2623231
  • UDI-DI: 00884450394946

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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