Food, drugs, devices › Resource Optimization & Innovation Llc
Device recall: Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.
FDA enforcement event 72052 is a device recall by Resource Optimization & Innovation Llc of Springfield, MO, initiated 25 Aug 2015 and classified Class II, with 8 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 6 Apr 2017. Initiation: voluntary: firm initiated. Resource Optimization & Innovation Llc has 9 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Resource Optimization & Innovation Llc, Springfield, MO.
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."
Distribution
"Distributed in Texas and Louisiana."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0184-2016 | Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery. | 84 kits | Class II | Terminated | 4 Nov 2015 |
| Z-0185-2016 | Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery. | 80 kits | Class II | Terminated | 4 Nov 2015 |
| Z-0186-2016 | Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery. | 77 kits | Class II | Terminated | 4 Nov 2015 |
| Z-0187-2016 | Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery. | 153 kits | Class II | Terminated | 4 Nov 2015 |
| Z-0188-2016 | Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery. | 57 kits | Class II | Terminated | 4 Nov 2015 |
| Z-0189-2016 | Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery. | 17 kits | Class II | Terminated | 4 Nov 2015 |
| Z-0190-2016 | Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery. | 28 kits | Class II | Terminated | 4 Nov 2015 |
| Z-0191-2016 | Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery. | 10 kits | Class II | Terminated | 4 Nov 2015 |
Context
Other enforcement events for Resource Optimization & Innovation Llc
All 9 events for Resource Optimization & Innovation Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed in Texas and Louisiana."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Apr 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.