Severity
Moderate
ModerateClass IIOngoing
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, …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-0169-2018) was formally reported on November 29, 2017, with the manufacturer initiating the action on September 25, 2017. It is classified under Moderate severity (Class II), with a current status of Ongoing. Resource Optimization & Innovation Llc is listed as the recalling firm, operating out of Springfield, MO. Federal records list the affected scope as 51 units.
The documented reason for this recall is: 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 uni… Distribution data in the federal record shows the product reached: Distributed domestically to Texas.. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
51 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.. Recalled by Resource Optimization & Innovation Llc. Units affected: 51 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2017. Severity: Moderate. Recall number: Z-0169-2018.
Where was the recalled product distributed? ▼
Distribution: Distributed domestically to Texas..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0169-2018) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 November 29, 2017. 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.