FDA Devices recall · Reported November 29, 2017
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
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, …
Resource Optimization & Innovation Llc recalled Regard Custom Surgical Pack Packs contain surgical instruments and accessories intende… - a moderate-severity action.
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intende… was recalled by Resource Optimization & Innovation Llc in November 29, 2017. Reason: Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml …. Check the official notice for the remedy. Verify recall #Z-0169-2018 with the FDA Devices before acting.
The recall
Resource Optimization & Innovation Llc issued this moderate-severity FDA Devices recall-Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ….
- Moderate
- severity level
- 51 units
- affected scope
- Class II
- classification
- November 29, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0169-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
Reason for 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0169-2018 |
| Date reported | November 29, 2017 |
| Date initiated | September 25, 2017 |
| Recalling firm | Resource Optimization & Innovation Llc |
| Firm location | Springfield, MO |
| Affected scope | 51 units |
| Distribution | Distributed domestically to Texas. |
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-0169-2018) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026