Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported April 3, 2013
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
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…
CareFusion 213, LLC recalled Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Pre… - a low-severity action.
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Pre… was recalled by CareFusion 213, LLC in April 3, 2013. Reason: An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. …. Check the official notice for the remedy. Verify recall #Z-1001-2013 with the FDA Devices before acting.
The recall
CareFusion 213, LLC issued this low-severity FDA Devices recall-An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. ….
- Low
- severity level
- 13.7M units
- affected scope
- Class III
- classification
- April 3, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1001-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1001-2013) was formally reported on April 3, 2013, with the manufacturer initiating the action on March 4, 2013. It is classified under Low severity (Class III), with a current status of Terminated. CareFusion 213, LLC is listed as the recalling firm, operating out of El Paso, TX. Federal records list the affected scope as 13,749,000, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: USA Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
13,749,000
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1001-2013 |
| Date reported | April 3, 2013 |
| Date initiated | March 4, 2013 |
| Recalling firm | CareFusion 213, LLC |
| Firm location | El Paso, TX |
| Affected scope | 13,749,000 |
| Distribution | USA Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1001-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product. Recalled by CareFusion 213, LLC. Units affected: 13,749,000.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2013. Severity: Low. Recall number: Z-1001-2013.
Where was the recalled product distributed? ▼
Distribution: USA Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1001-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 3, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.