FDA (Devices) recall action 71904

Resource Optimization & Innovation Llc recalled 77 products on 2015-10-14

The FDA (Devices) publishes a recall like this one as 77 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 77 pages.

Products: 77
Announced: 2015-10-14
Critical: 0
Units: 38,056

Why these products were recalled

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 77

HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls 874 Sterile Surgical Kits
Resource Optimization & Innovation LLC is recalling 874 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgi
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
FDA Recalls Sterile Surgical Kits Due to Potential Sterility Compromise
Resource Optimization & Innovation LLC is recalling 3,099 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgica
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls 124 Sterile Arthroscopy Surgical Kits
Resource Optimization & Innovation LLC is recalling 124 sterile arthroscopy surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgi
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 600 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Orthopedic Surgical Kits
Resource Optimization & Innovation LLC is recalling 1,476 sterile orthopedic surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical pr
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Pediatric Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 158 pediatric surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a su
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Shoulder Surgical Kits
Resource Optimization & Innovation LLC is recalling 832 sterile shoulder surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a s
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 54 sterile open heart surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surg
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 108 sterile open heart surgical kits because an equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800569, Sterile, CV0659 - Open Heart A & B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surg
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
FDA Recalls 230 Sterile C-Section Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 230 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Head and Neck Surgical Kits
Resource Optimization & Innovation LLC is recalling 156 sterile surgical kits because a component may have splits or holes that compromise sterility.
Product
regard Item Number: 800526, Sterile, ET0610 - Head and Neck - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgica
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
FDA Recalls 146 Sterile C-Section Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 146 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800508, Sterile, LD0586 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical p
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
FDA Recalls 164 Neuro Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 164 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical pro
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
FDA Recalls Robotic Hysterectomy Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 324 robotic hysterectomy surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use duri
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 36 sterile Open Heart surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a s
Category
Distribution
3 states
SevereFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 199 sterile open heart surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgic
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation LLC Recalls Pediatric Surgical Kits
Resource Optimization & Innovation LLC is recalling 136 sterile pediatric surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a su
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Titanium Rib Surgical Kits
Resource Optimization & Innovation LLC is recalling 62 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgi
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Risk
Resource Optimization & Innovation LLC is recalling 1,220 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800419, Sterile, GY0488 - D&C Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical proc
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Risk
Resource Optimization & Innovation LLC is recalling 7,904 sterile surgical kits because the equipment glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical proc
Category
Distribution
3 states
SevereFDA (Devices)··2015-10-14
FDA Recalls 214 Sterile Neuro Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 214 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 26 sterile C-section surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical pr
Category
Distribution
3 states
SevereFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Vaginal Hysterectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 36 vaginal hysterectomy surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO Custom procedure tray contains surgical instruments and accessories intended for use during a s
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Hip Shoulder Surgical Kits
Resource Optimization & Innovation LLC is recalling 125 sterile hip shoulder surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Laparoscopy Surgical Kits
Resource Optimization & Innovation LLC is recalling 400 sterile laparoscopy surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgi
Category
Distribution
3 states