CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surg...

FDA Recall #D-1359-2014 — Class II — December 20, 2013

Recall #D-1359-2014 Date: December 20, 2013 Classification: Class II Status: Terminated

Product Description

CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18

Reason for Recall

Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.

Recalling Firm

Carefusion 2200 Inc — Vernon Hills, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2,443,500 scrub brushes

Distribution

Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines

Code Information

4451B; 4451GL

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated