FDA (Devices) recall action 91984

ROi CPS LLC recalled 8 products on 2023-05-03

The FDA (Devices) publishes a recall like this one as 8 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 8 pages.

Products: 8
Announced: 2023-05-03
Critical: 0
Units: 4,855

Why these products were recalled

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

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

1–8 of 8

HighFDA (Devices)··2023-05-03
Surgical Convenience Kits Recalled Due to Separating Light Handle Covers
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - An
Category
Distribution
2 states
HighFDA (Devices)··2023-05-03
Sterile surgical kit recalled due to light handle cover separation risk
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. Approximately 70 kits were distributed in Florida and Missouri.
Product
Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
Category
Distribution
2 states
HighFDA (Devices)··2023-05-03
Surgical Kit Light Handle Covers May Separate During Use
ROi CPS LLC is recalling 1,369 sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed nationwide in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthro
Category
Distribution
2 states
HighFDA (Devices)··2023-05-03
Sterile surgical C-section kit light handle covers recalled for separation risk
ROi CPS LLC recalls sterile surgical C-section kits due to light handle covers that may separate and fall during use. The recall affects 1,312 kits distributed in Florida and Missouri.
Product
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
Category
Distribution
2 states
HighFDA (Devices)··2023-05-03
Surgical Convenience Kits Recalled for Separating Light Handle Covers
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The recall affects 278 kits distributed in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
Category
Distribution
2 states
HighFDA (Devices)··2023-05-03
Sterile Surgical Kit Light Handle Covers May Separate During Use
ROi CPS LLC is recalling 386 sterile surgical convenience kits (WPH GYN Laparoscopy Pack) because light handle covers may separate and fall off during use.
Product
Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
Category
Distribution
2 states
HighFDA (Devices)··2023-05-03
Sterile surgical cardiac catheterization kit recalled for light handle cover separation
A sterile surgical convenience kit for cardiac catheterization is being recalled because light handle covers may separate and fall off during use. The affected lot includes 322 kits distributed to Florida and Missouri.
Product
Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
Category
Distribution
2 states
HighFDA (Devices)··2023-05-03
Sterile Surgical Kits Recalled Due to Light Handle Cover Separation Risk
ROi CPS LLC is recalling 662 sterile surgical convenience kits because light handle covers may separate from the light handle and fall off during use. The kits were distributed in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - O
Category
Distribution
2 states