# FDA recall D-228-2013

> **CareFusion 213, LLC** · Class II · drug recall initiated 2013-03-04.

## Product

Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99, CareFusion, Leawood, KS  66211.

## Reason for recall

Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.

## Distribution

Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom

## Key facts

- **Recall number:** D-228-2013
- **Recalling firm:** CareFusion 213, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-03-04
- **Report date:** 2013-04-03
- **Termination date:** 2014-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** El Paso, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-228-2013

## Citation

> AI Analytics. FDA recall D-228-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-228-2013. Source: US FDA. Licensed CC0.

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