CLASS II Device recall · Reported 5 Apr 2017 · FDA Enforcement Report
Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack recalled
Resource Optimization & Innovation is recalling Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack, distributed in Louisiana, Texas. The recall was initiated on 9 Jan 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-1591-2017
- FDA event ID
- 76255
- Recalling firm
- Resource Optimization & Innovation, Springfield, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jan 2017
- FDA classified
- 24 Mar 2017
- Reported
- 5 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 9 Jan 2017 | Recall initiated by company | |
| 24 Mar 2017 | Classified by FDA | +74 days |
| 5 Apr 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover Hills
Where it was distributed
US Distribution to LA and TX.
Questions about this recall
Is Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack recalled?
Yes. Resource Optimization & Innovation recalled Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack on 9 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-1591-2017.
Why was it recalled?
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Which lots are affected?
031066A Exp Date 2018-01-21; 031996A Exp Date 2018-03-02; 033021A Exp Date 2018-04-19
Where was it sold?
US Distribution to LA and TX.
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 Custom Surgical Pack Packs contain surgical recalled | Resource Optimization & Innovation | Labeling Errors | TX |
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