The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2193-2013·Announced 2013-09-18

CareFusion Recalls Thoracentesis Trays Due to Catheter Occlusion Risk

CareFusion is recalling Thoracentesis and Safe-T Thoracentesis Trays because the included catheters may occlude, potentially delaying medical procedures and causing patient complications.

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: The recall is classified as FDA Class II, and the source text describes a risk of 'potentially serious patient complications' without reporting specific injuries or deaths, fitting the criteria for a High severity score.

Plain-English summary

CareFusion 2200 Inc is recalling specific lots of Thoracentesis Trays (Cat. 4341B) and Safe-T Thoracentesis Trays - Drug Free (Cat. 4341BSDF). The recall involves 174,580 units of the standard tray and 23,330 units of the Safe-T tray. These medical devices are indicated for specimen retrieval and therapeutic drainage of the pleural cavity.

The recall was initiated because the catheters included in these trays may occlude. This occlusion can prevent the drainage of excessive fluid from the pleural cavity, leading to a potential delay in the medical procedure and potentially serious patient complications.

The affected products were distributed nationwide in the United States, including Puerto Rico, and in Iceland. Healthcare facilities and consumers who have these specific product codes and lot numbers should stop using the devices and contact CareFusion for instructions on return or replacement.

The recalled product

Product
*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road…
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instruments
Hazard

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 (20)

  • *** 1) Product Code: 4341B
  • Lots: 554361 (Expires 11/30/15)
  • 550463 (Expires 11/30/15)
  • 548675 (Expires 11/30/15)
  • 545891 (Expires 10/31/15)
  • 544746 (Expires 10/31/15)
  • 543978 (Expires 10/31/15)
  • 542297 (Expires 10/31/15)
  • 541063 (Expires 10/31/15)
  • 539859 (Expires 10/31/15)
  • 539470 (Expires 10/31/15)
  • 537723 (Expires 9/30/15)
  • 536497 (Expires 9/30/15)
  • 535600 (Expires 9/30/15)
  • 534616 (Expires 9/30/15)
  • 532917 (Expires 8/31/15)
  • 531869 (Expires 8/31/15)
  • 530729 (Expires 8/31/15)
  • 528789 (Expires 8/31/15)
  • 526724 (Expires 8/31/15)

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically:

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