FDA Device recall Z-1001-2013
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk
- FDA Device
- Class III
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class III recall of Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk by Carefusion 213, citing 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 cont….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1001-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-03-04 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carefusion 213 |
| Distribution | US |
Product
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
Reason
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.
Identifiers
| code_info | Tincture Packaged: Product Number 260619 and Product ID D086353; Tincture 3,000 Bulk: Product Number 260520 and Product ID D086353. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1001-2013%22
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