Food, drugs, devices › Resource Optimization & Innovation Llc

Device recall: Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland

FDA enforcement event 76255 · Class II · initiated 9 Jan 2017 · status Terminated · terminated 28 Sep 2018

DeviceVoluntary: Firm initiated135 product recordsSpringfield, MO

Resource Optimization & Innovation Llc (Springfield, MO) initiated this device recall on 9 Jan 2017; FDA lists 135 product records under event 76255, classified Class II.

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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 28 Sep 2018. 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 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."

Distribution

"US Distribution to LA and TX."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1544-2017	Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland	41 kits	Class II	Terminated	5 Apr 2017
Z-1545-2017	Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels	46 kits	Class II	Terminated	5 Apr 2017
Z-1546-2017	Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa	210 kits	Class II	Terminated	5 Apr 2017
Z-1547-2017	Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa Rosa	90 kits	Class II	Terminated	5 Apr 2017
Z-1548-201	Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn	2,122 kits	Class II	Terminated	5 Apr 2017
Z-1549-2017	Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn	208 kits	Class II	Terminated	5 Apr 2017
Z-1550-201	Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Santa Rosa	55 kits	Class II	Terminated	5 Apr 2017
Z-1551-2017	Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn	112 kits	Class II	Terminated	5 Apr 2017
Z-1552-2017	Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU	6 kits	Class II	Terminated	5 Apr 2017
Z-1553-2017	Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hills	420 kits	Class II	Terminated	5 Apr 2017
Z-1554-2017	Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis	320 kits	Class II	Terminated	5 Apr 2017
Z-1555-2017	Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels	88 kits	Class II	Terminated	5 Apr 2017
Z-1556-2017	Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels	46 kits	Class II	Terminated	5 Apr 2017
Z-1557-2017	Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU	16 kits	Class II	Terminated	5 Apr 2017
Z-1558-2017	Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSU	14 Kits	Class II	Terminated	5 Apr 2017
Z-1559-2017	Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU	156 kits	Class II	Terminated	5 Apr 2017
Z-1560-2017	Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU	30 kits	Class II	Terminated	5 Apr 2017
Z-1561-2017	Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU	42 kits	Class II	Terminated	5 Apr 2017
Z-1562-2017	Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU	1,548 kits	Class II	Terminated	5 Apr 2017
Z-1563-2017	Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU	48 kits	Class II	Terminated	5 Apr 2017
Z-1564-2017	Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B - OSU	27 kits	Class II	Terminated	5 Apr 2017
Z-1565-2017	Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU	16 kits	Class II	Terminated	5 Apr 2017
Z-1566-2017	Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSU	32 kits	Class II	Terminated	5 Apr 2017
Z-1567-2017	Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU	28 kits	Class II	Terminated	5 Apr 2017
Z-1568-2017	Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU	26 kits	Class II	Terminated	5 Apr 2017
Z-1569-2017	Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU	18 kits	Class II	Terminated	5 Apr 2017
Z-1570-2017	Regard, Item Number: 880330004, Sterile, OR0761D - Total Hip - OSU	18 kits	Class II	Terminated	5 Apr 2017
Z-1571-2017	Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU	14 kits	Class II	Terminated	5 Apr 2017
Z-1572-2017	Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU	22 kits	Class II	Terminated	5 Apr 2017
Z-1573-2017	Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU	8 kits	Class II	Terminated	5 Apr 2017
Z-1574-2017	Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU	704 kits	Class II	Terminated	5 Apr 2017
Z-1575-2017	Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU	170 kits	Class II	Terminated	5 Apr 2017
Z-1576-2017	Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU	248 kits	Class II	Terminated	5 Apr 2017
Z-1577-2017	Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU	78 kits	Class II	Terminated	5 Apr 2017
Z-1578-2017	Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU	30 kits	Class II	Terminated	5 Apr 2017
Z-1579-2017	Regard, Item Number: 800407002, Sterile, OR0476B - Ortho PK - Spohn	460 kits	Class II	Terminated	5 Apr 2017
Z-1580-2017	Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn	117 kits	Class II	Terminated	5 Apr 2017
Z-1581-2017	Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn	96 kits	Class II	Terminated	5 Apr 2017
Z-1582-2017	Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn	120 kits	Class II	Terminated	5 Apr 2017
Z-1583-2017	Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn	86 kits	Class II	Terminated	5 Apr 2017
Z-1584-2017	Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn	28 kits	Class II	Terminated	5 Apr 2017
Z-1585-2017	Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn	36 kits	Class II	Terminated	5 Apr 2017
Z-1586-2017	Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn	48 kits	Class II	Terminated	5 Apr 2017
Z-1587-2017	Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper	10 kits	Class II	Terminated	5 Apr 2017
Z-1588-2017	Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover Hills	70 kits	Class II	Terminated	5 Apr 2017
Z-1589-2017	Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills	344 kits	Class II	Terminated	5 Apr 2017
Z-1590-2017	Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover Hills	180 kits	Class II	Terminated	5 Apr 2017
Z-1591-2017	Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover Hills	456 kits	Class II	Terminated	5 Apr 2017
Z-1592-2017	Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack - Westover Hills	590 kits	Class II	Terminated	5 Apr 2017
Z-1593-2017	Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck - Westover Hills	54 kits	Class II	Terminated	5 Apr 2017
Z-1594-2017	Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills	15 kits	Class II	Terminated	5 Apr 2017
Z-1595-2017	Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover Hills	12 kits	Class II	Terminated	5 Apr 2017
Z-1596-2017	Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover Hills	40 kits	Class II	Terminated	5 Apr 2017
Z-1597-2017	Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover Hills	45 kits	Class II	Terminated	5 Apr 2017
Z-1598-2017	Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills	834 kits	Class II	Terminated	5 Apr 2017
Z-1599-2017	Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills	460 kits	Class II	Terminated	5 Apr 2017
Z-1600-2017	Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills	200 kits	Class II	Terminated	5 Apr 2017
Z-1601-2017	Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills	290 kits	Class II	Terminated	5 Apr 2017
Z-1602-2017	Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels	40 kits	Class II	Terminated	5 Apr 2017
Z-1603-2017	Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels	40 kits	Class II	Terminated	5 Apr 2017

Showing 60 of 135 product records; the FDA enforcement report lists all of them.

Context

93%of 2017 device events are Class II1,091 events that year

135product records in this eventfirm median: 2

9events on this register for the firm

Other enforcement events for Resource Optimization & Innovation Llc

Initiated	Product (first record)	Type	Class	Records
28 Feb 2022	Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site	Device	Class II	1
17 Jun 2020	regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indic	Device	Class II	1
4 May 2020	Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used onl	Device	Class II	2
25 Sep 2017	Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical proced	Device	Class II	1
25 Aug 2015	Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.	Device	Class II	8
25 Aug 2015	Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments an	Device	Class II	1
19 Aug 2015	Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.	Device	Class II	2
22 Apr 2015	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The respo	Device	Class II	77

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 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."

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: "US Distribution to LA and TX."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 28 Sep 2018. "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.