Resource Optimization & Innovation, LLC

Activity by year

Devices registered here (3)

• Medical Glove, Specialty
  Product code LZC (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6250
• Polymer Patient Examination Glove
  Product code LZA (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6250
• Fentanyl And Other Opioid Protection Glove
  Product code QDO (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6250

Recalls & enforcement

• Class IITerminated2022-02-28
  A kit component, the PDI Prevantics Swab, was recalled.
• Class IITerminated2020-06-17
  The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.
• Class IITerminated2020-05-04
  There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
• Class IIOngoing2017-09-25
  Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 7096622. The label mix is at the unit level where a "ChloraPrep One-Step" unit label was incorrec…
• Class IITerminated2017-01-09
  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.
• Class IITerminated2015-08-25
  The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.
• Class IITerminated2015-08-25
  Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
• Class IITerminated2015-08-19
  Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
• Class IITerminated2015-04-22
  The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

FDA inspections (1)

• VAI2019-04-04
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

• All facilities operated by Resource Optimization & Innovation

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)