The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2281-2013·Announced 2013-10-02

CareFusion Recalls Gravity Sets Due to Incorrect Expiration Date Labeling

CareFusion is recalling 2,850 units of Gravity Set Model 44000-07 because they are labeled with a 5-year expiration date instead of the correct 3-year date.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a labeling error (incorrect expiration date) with no reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

CareFusion 303, Inc. is recalling 2,850 units of the CareFusion Gravity Set, Model #44000-07. These medical devices are used to administer fluid and medication through a needle or catheter inserted into a patient's artery or vein. The set includes components such as a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp, and tubing.

The recall is being conducted because the affected lots are labeled with an incorrect expiration date. Specifically, the products are marked with a 5-year expiration date instead of the correct 3-year expiration date. The affected lot numbers are 12086930, 12106215, 13016408, 13016834, 13025446, and 13025672.

The affected units were distributed in Illinois. Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected products. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular…
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard
Affected units
2,850

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 Numbers: 12086930
  • 12106215
  • 13016408
  • 13016834
  • 13025446
  • and 13025672.

Distribution

Distributed in 1 state:

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