CLASS II Device recall · Reported 5 Apr 2017 · FDA Enforcement Report

Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B recalled

Resource Optimization & Innovation is recalling Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B, distributed in Louisiana, Texas. The recall was initiated on 9 Jan 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes033453G Exp Date 2018-04-30;

Quantity recalled27 kits

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-1564-2017
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: E-Mail
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: 880327007, Sterile, CV0758G - Open Heart A&B - OSU

Where it was distributed

US Distribution to LA and TX.

Louisiana Texas

Questions about this recall

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?

033453G Exp Date 2018-04-30;

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

100 other products · FDA event 76255

This product is part of a recall event; the main page for the event is Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck recalled.

Reported	Class	Recall	Company	Reason	Where
5 Apr 2017	CLASS II	Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800567003, Sterile, GY0656C - Robotic recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800558003, Sterile, OR0647C - Extremity recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880328002, Sterile, HT0759B recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800413005, Sterile recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800415001, Sterile, OR0484A recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880328001, Sterile, HT0759A recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800091002, Sterile, LD0692B - C Section - Fmol recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800557001, Sterile, LD0646A - C Section recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800508004, Sterile, LD0586D recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800562002, Sterile, NU0651B - Neuro - Childrens recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800524003, Sterile, LD0608C - C Section recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800558004, Sterile, OR0647D - Extremity recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800553003, Sterile, OR0642C - Total Knee recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880330004, Sterile, OR0761D - Total Hip - OSU recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800557002, Sterile, LD0646B - C Section recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800091003, Sterile, LD0692C - C Section - Fmol recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880341001, Sterile, GS0775A recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800508004, Sterile, LD0586D recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800413004, Sterile recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800413003, Sterile, CV0482C recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800559002, Sterile, ET0648B - Head & Neck recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800546002, Sterile, GS0635B - Abdominal recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800508003, Sterile, LD0586C recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - Spohn recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800416001, Sterile, GY0485A - Robotic recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800548002, Sterile, OR0637B - Extremity recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800558002, Sterile, OR0647B - Extremity recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800508001, Sterile, LD0586A recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800508002, Sterile, LD0586B recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800524004, Sterile, LD0608D - C Section recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU recalled	Resource Optimization & Innovation	Sterility	LA, TX
5 Apr 2017	CLASS II	Regard, Item Number: 880341003, Sterile, GS0775C recalled	Resource Optimization & Innovation	Sterility	LA, TX

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24 Jun 2020Device	CLASS II	Regard SRHS GIC Port A Cath, Sterile, Qty recalled	Resource Optimization & Innovation	Sterility	Nationwide
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