The Recall Desk
ModerateFDA (Drugs)·D-1360-2014·Announced 2014-06-11

CareFusion Recalls Surgical Scrub Brushes With Low Iodine Levels

CareFusion is recalling surgical scrub brushes because the available iodine content is lower than stated on the label.

What this means for you

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 source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a subpotent formulation rather than a high-risk pathogen or structural defect.

Plain-English summary

CareFusion 2200 Inc is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The recall is due to the product being subpotent, meaning the available iodine in the product is less than the amount stated on the product label.

The affected product is the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub, NDC 57613-013-15. The recall involves 1,662,000 surgical scrub brushes. The products were distributed nationwide and in Puerto Rico, as well as in Bahrain, Germany, Mexico, and the Philippines.

Consumers and healthcare facilities should stop using the affected products and contact CareFusion for further instructions or a replacement.

The recalled product

Product
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15.
Affected units
1,662,000

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 (1)

  • 4452B

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Carefusion 2200 Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →