The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1912-2023·Announced 2023-06-21

Aspira Pleural Drainage Catheter Insertion Tray recalled for valve assembly malfunction

Merit Medical Systems is recalling the Aspira Pleural Drainage Catheter Insertion Tray because valve assemblies may not open, preventing proper 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 an FDA Class II recall involving a medical device with a functional failure risk. No hospitalizations or injuries have been reported. The hazard—valve assembly failure preventing fluid drainage—qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric for High severity.

Plain-English summary

Merit Medical Systems, Inc. is recalling the Aspira Pleural Drainage Catheter Insertion Tray (Reference 4992506, Version A, UDI-DI 00884450398173). The recall involves 156 units distributed nationwide in the United States, Puerto Rico, and to France, the United Kingdom, and Mexico.

The catheter insertion tray may have valve assemblies that fail to open properly. When valve assemblies do not open, fluid cannot drain as intended, potentially compromising the device's critical drainage function.

Affected lot numbers are I2632727, I2558682, I2623159, and I2618461. Healthcare facilities and medical professionals who have received affected units should discontinue use and contact Merit Medical Systems for instructions on returns or replacement.

The recalled product

Product
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device
Hazard
Affected units
156

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 # I2632727
  • I2558682
  • I2623159
  • I2618461
  • UDI-DI: 00884450398173

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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