Regard Custom Surgical Packs Recall: Incorrect Label Risk
Resource Optimization & Innovation recalls Regard Custom Surgical Packs with incorrect ChloraPrep labels that could lead to wrong surgical solution use. Affected units have a "ChloraPrep One-Step" label instead of "ChloraPrep With Tint".
Lower-risk recall
Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 7096622. The label mix is at the unit level where a "ChloraPrep One-Step" unit label was incorrectly used on a certain percentage of the impacted lot instead of the correct "ChloraPrep With Tint" label. The recall notification was issued by BD on September 15, 2017 and was received by ROi on September 18, 2017. Because the 3ml ChloraPrep With Tint product is contained within select ROi Regard Custom Surgical Packs, ROi is conducting a recall of the affected ROi Regard Custom Surgical Packs.
Contact the company
What happened, in plain English
Resource Optimization & Innovation is recalling Regard Custom Surgical Packs that contain a surgical solution with an incorrect label. This could cause the wrong solution to be used during surgery if the label is not checked properly. Read more at govinfonow.com/recall/72948-regard-custom-surgical-packs-recall-incorrect-label-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/72948-regard-custom-surgical-packs-recall-incorrect-label-risk · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0169-2018
Cite this page
“Regard Custom Surgical Packs Recall: Incorrect Label Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72948-regard-custom-surgical-packs-recall-incorrect-label-risk. Based on FDA recall #Z-0169-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0169-2018%22&limit=1).
Why it’s dangerous
The label on the 3ml ChloraPrep solution inside the packs is incorrect. Instead of the proper "ChloraPrep With Tint" label, some units have a "ChloraPrep One-Step" label. This could lead to using the wrong solution during surgery if not noticed.
Who’s affected
Surgical teams using Regard Custom Surgical Packs with the incorrect label. The risk is low as the label error is specific to a small percentage of units and does not cause immediate harm.
How to tell if you have this one
Check for a "ChloraPrep One-Step" label on the 3ml ChloraPrep solution inside the pack. The affected packs have Item No. 800620003 and Lot No. 047005C.
- Brand
Resource Optimization & Innovation- Category
Medical device
What to do — step by step
Check Label
Look for a "ChloraPrep One-Step" label on the 3ml ChloraPrep solution inside the pack instead of the correct "ChloraPrep With Tint" label.
Where it went and when
Where it was distributed
Distributed in Texas.
FDA distribution: “Distributed domestically to Texas.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0169-2018 (September 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0169-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.