Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Sepp Recalled by CareFusion 213, LLC Due to An internal review of CareFusion's labeling for preoperative...

Date: March 4, 2013
Company: CareFusion 213, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact CareFusion 213, LLC directly.

Affected Products

Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product

Quantity: 13,749,000

Why Was This Recalled?

An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CareFusion 213, LLC

CareFusion 213, LLC has 29 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report