CLASS II ONGOING Device recall · Reported 29 Nov 2017 · FDA Enforcement Report
Regard Custom Surgical Pack Packs contain surgical recalled
Resource Optimization & Innovation is recalling Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended, distributed in Texas. The recall was initiated on 25 Sep 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0169-2018
- FDA event ID
- 78377
- Recalling firm
- Resource Optimization & Innovation, Springfield, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Sep 2017
- FDA classified
- 21 Nov 2017
- Reported
- 29 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Surgical Instruments
Timeline
| 25 Sep 2017 | Recall initiated by company | |
| 21 Nov 2017 | Classified by FDA | +57 days |
| 29 Nov 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
Where it was distributed
Distributed domestically to Texas.
Questions about this recall
Is Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended recalled?
Yes. Resource Optimization & Innovation recalled Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended on 25 Sep 2017. The recall is Class II and its status is Ongoing. Recall number Z-0169-2018.
Why was it 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 lots are affected?
Item No. 800620003, Lot No. 047005C, Exp. Date 08/15/2019
Where was it sold?
Distributed domestically to Texas.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Resource Optimization & Innovation
All 228| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Regard IV Start Kit for preparing and/or dressing recalled | Resource Optimization & Innovation | Other | MO |
| Device | CLASS II | regard Migrating Indicator, Steam Migrating Indicator Strips recalled | Resource Optimization & Innovation | Sterility | Nationwide |
| Device | CLASS II | Regard SRHS GIC Port A Cath, Sterile, Qty recalled | Resource Optimization & Innovation | Sterility | Nationwide |
| Device | CLASS II | Regard SRHS Central Line Kit, Sterile recalled | Resource Optimization & Innovation | Sterility | Nationwide |
| Device | CLASS II | Regard, Item Number: 800558001, Sterile, OR0647A - Extremity recalled | Resource Optimization & Innovation | Sterility | LA, TX |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |