Z-1001-2013Class III

Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk

Name: Z-1001-2013 Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk
Creator: CareFusion 213, LLC
Published: 2013-03-04
License: https://open.fda.gov/license/

CareFusion 213 LLC / initiated 2013-03-04 / Terminated / root cause: labeling and UDI

FDA source

CareFusion 213, LLC began a recall of Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product on 2013-03-04. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1001-2013
Classification: Class III
Status: Terminated
Initiated: 2013-03-04
Posted: 2013-03-26
Terminated: 2014-05-12
Recalling firm: CareFusion 213 LLC
Product: Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
Product code: OJU Skin Prep Tray
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: CareFusion sent an Urgent Recall Notice dated March 4, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately check inventory, quarantine and return the affected product for replacement. For questions call (913) 345-3504.
Quantity in commerce: 13,749,000
Distribution: USA Nationwide Distribution
Product codes and lots: Tincture Packaged: Product Number 260619 and Product ID D086353; Tincture 3,000 Bulk: Product Number 260520 and Product ID D086353.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1001-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1001-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-26

Product code OJU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)