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
Resource Optimization & Innovation Recalls Sterile Head and Neck Surgical Kits
Resource Optimization & Innovation LLC is recalling 381 sterile Head & Neck surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800559, Sterile, ET0648 - Head & 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 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 s
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 pr
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls 840 Sterile Surgical Extremity Packs
Resource Optimization & Innovation LLC is recalling 840 sterile surgical extremity packs because the equipment glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800525, Sterile, OR0609 - Extremity 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 surgic
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Robotic Hysterectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 30 sterile robotic hysterectomy surgical kits because the equipment glove component may have splits or holes that compromise sterility.
Product
regard Item Number 800567001, Sterile, GY0656A - 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 durin
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile AV Access Surgical Kits
Resource Optimization & Innovation LLC is recalling 192 sterile AV Access surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn 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 sur
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 surgical
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation LLC Recalls Sterile Surgical Kits
Resource Optimization & Innovation LLC is recalling 1,144 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800533, Sterile, GS0606 - Abdominal 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
SevereFDA (Devices)··2015-10-14
FDA Recalls 726 Sterile Laparoscopic Cholecystectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 726 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800551, Sterile, GS0640 - 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 pr
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls 158 Sterile Titanium Rib Surgical Kits
Resource Optimization & Innovation LLC is recalling 158 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800568, Sterile, OR0658 - 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 surgical
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 surgi
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
FDA Recalls Sterile Neuro Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 904 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800411, Sterile, NU0480 - 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
Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 24 sterile surgical kits because a component may have splits or holes that compromise sterility.
Product
regard Item Number: 800597, Sterile, GY0688 - LAVH - 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 procedu
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 surgical
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 440 sterile open heart surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800410001, Sterile, CV0479A - 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 sur
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 144 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800535, Sterile, LD0620 - 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
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 pr
Category
Distribution
3 states
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 pro
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
FDA Recalls Pediatric Heart Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 57 pediatric heart surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number 800565001, Sterile, CV0654A - 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 su
Category
Distribution
3 states
SevereFDA (Devices)··2015-10-14
FDA Recalls Pacemaker Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 40 pacemaker surgical kits because equipment gloves may have splits or holes that compromise sterility.
Product
regard Item Number: 880328, Sterile, HT0759 - Pacemaker 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 Hip Shoulder Surgical Kits
Resource Optimization & Innovation LLC is recalling 92 sterile hip shoulder surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder 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 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 pr
Category
Distribution
3 states
HighFDA (Devices)··2015-10-14
FDA Recalls 88 Sterile Lap Chole Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 88 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800560001, Sterile, GS0649A - 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 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 sur
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 surgi
Category
Distribution
3 states