Sepp — Class III medical device recall Z-1001-2013
Terminated recall by CareFusion 213, LLC, reported 2013-04-03, distributed nationwide. An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. T
| Recall number | Z-1001-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2013-03-04 |
| Classified | 2013-03-26 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2014-05-12 |
| Distributed | Nationwide (US) |
| Quantity | 13,749,000 |
| Reason classes | labeling, sterility |
Product
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1001-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.