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

51–75 of 77

HighFDA (Devices)··2015-10-14
FDA Recalls 48 Neuro Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 48 sterile neuro surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 800531, Sterile, NU0615 - 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 LLC Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 72 sterile C-section surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 880323, Sterile, LD0754 - 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 164 Arthroscopy Surgical Kits
Resource Optimization & Innovation LLC is recalling 164 arthroscopy surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 800422001, Sterile, OR0491A - 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…
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Total Knee Surgical Kits
Resource Optimization & Innovation LLC is recalling 40 sterile total knee surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 880331, Sterile, OR0762 - Total Knee - 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 Abdominal Surgical Kits
Resource Optimization & Innovation LLC is recalling 712 sterile abdominal surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800546, Sterile, GS0635 - Abdominal - 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
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…
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
FDA Recalls 658 Sterile Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 658 sterile surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - 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…
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…
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…
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile C Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 388 sterile C Section surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800036003, Sterile, LD0274C - C Section Pack - 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…
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 1,400 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800408001, Sterile, LD0477A - 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…
Category
Distribution
3 states
SevereFDA (Devices)··2015-10-14
FDA Recalls 24 Sterile Breast Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 24 sterile breast surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, 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 516 Sterile Lap Chole Surgical Kits
Resource Optimization & Innovation LLC is recalling 516 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800528, Sterile, GS0612 - 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…
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…
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…
Category
Distribution
3 states
SevereFDA (Devices)··2015-10-14
FDA Recalls Robotic Hysterectomy Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 144 robotic hysterectomy surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800567, Sterile, GY0656 - Robotic 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…
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 416 sterile C-section surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800557, Sterile, LD0646 - 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 LLC Recalls Sterile Extremity Surgical Kits
Resource Optimization & Innovation LLC is recalling 672 sterile extremity surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800548, Sterile, OR0637 - Extremity - 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 LLC Recalls Pediatric Cardiac Catheterization Surgical Kits
Resource Optimization & Innovation LLC is recalling 24 pediatric cardiac catheterization surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - 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…
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 68 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800091001, Sterile, LD0692A - 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…
Category
Distribution
3 states
SevereFDA (Devices)··2015-10-14
Resource Optimization & Innovation LLC Recalls Pediatric Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 24 pediatric heart surgical kits due to potential sterility compromise from defective equipment gloves.
Product
regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - 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…
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
FDA Recalls 924 Sterile Lap Chole Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 924 sterile surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 800528001, Sterile, GS0612A - 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…
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls 288 Sterile Vascular Surgical Kits
Resource Optimization & Innovation LLC is recalling 288 sterile vascular surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800413, Sterile, CV0482 - Vascular 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…
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
FDA Recalls 448 Sterile Laparoscopic Cholecystectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 448 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800560, Sterile, GS0649 - Lap Chole - 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 the equipment glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800407001, Sterile, OR0476A - 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…
Category
Distribution
3 states