CLASS II Device recall · Reported 4 Nov 2015 · FDA Enforcement Report
Regard, Item Number 830054001, CV00625A - Open Heart A&B - Custom recalled
Resource Optimization & Innovation is recalling Regard, Item Number 830054001, CV00625A - Open Heart A&B - Custom, distributed in Louisiana, Texas. The recall was initiated on 25 Aug 2015 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-0187-2016
- FDA event ID
- 72052
- Recalling firm
- Resource Optimization & Innovation, Springfield, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Aug 2015
- FDA classified
- 29 Oct 2015
- Reported
- 4 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 25 Aug 2015 | Recall initiated by company | |
| 29 Oct 2015 | Classified by FDA | +65 days |
| 4 Nov 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
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 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
Where it was distributed
Distributed in Texas and Louisiana.
Questions about this recall
Is Regard, Item Number 830054001, CV00625A - Open Heart A&B - Custom recalled?
Yes. Resource Optimization & Innovation recalled Regard, Item Number 830054001, CV00625A - Open Heart A&B - Custom on 25 Aug 2015. The recall is Class II and its status is Terminated. Recall number Z-0187-2016.
Why was it recalled?
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Which lots are affected?
22404, 23406, 23642, and 24032
Where was it sold?
Distributed in Texas and Louisiana.
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 |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |