Roi Cps recalls

Roi Cps appears in 86 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• regard BASIC NEURO, NU00259S, Item Number 800021019
  FDA Device · Class II · 2022-11-30 · Roi Cps
  Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
• regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006
  FDA Device · Class II · 2022-11-30 · Roi Cps
  Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
• regard NEURO PACK, NU00278L, Item Number 800040012
  FDA Device · Class II · 2022-11-30 · Roi Cps
  Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
• regard SPINE PACK, NU00260H, Item Number 800022008
  FDA Device · Class II · 2022-11-30 · Roi Cps
  Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
• regard SHOULDER, GS00828G, Item Number 880367007
  FDA Device · Class II · 2022-11-30 · Roi Cps
  Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
• Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother
  FDA Device · Class II · 2022-07-27 · Roi Cps
  Reason: Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
• Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle
  FDA Device · Class II · 2022-07-27 · Roi Cps
  Reason: Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
• regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile
  FDA Device · Class II · 2022-07-06 · Roi Cps
  Reason: A nonsterile component was packaged in a sterile convenience kit.
• regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
  FDA Device · Class II · 2022-06-15 · Roi Cps
  Reason: Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.
• Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
  FDA Device · Class II · 2022-06-15 · Roi Cps
  Reason: Potential for the tip of the electrode to detach during use.
• Regard brand CABG Pack A and B - Spartanburg
  FDA Device · Class II · 2022-05-18 · Roi Cps
  Reason: Kits were packed into shipping boxes incorrectly.
• Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mot…
  FDA Device · Class II · 2022-05-04 · Roi Cps
  Reason: A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
• Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Bi…
  FDA Device · Class II · 2022-05-04 · Roi Cps
  Reason: A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
• Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery…
  FDA Device · Class II · 2022-05-04 · Roi Cps
  Reason: A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
• Regard Custom Procedure Kits containing BD Luer Lok Access Devices
  FDA Device · Class III · 2022-04-06 · Roi Cps
  Reason: Recalled devices were packaged in convenience kits.
• Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
  FDA Device · Class II · 2022-03-09 · Roi Cps
  Reason: Products are mislabeled with the incorrect product identification on individual kit labeling.
• Regard, T AND A - Rogers, sterilized convenience kits
  FDA Device · Class II · 2022-01-19 · Roi Cps
  Reason: Kits lacks rubber latex warning label.
• regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles
  FDA Device · Class II · 2021-12-29 · Roi Cps
  Reason: The kit contains a non-sterile needle.
• REGARD Vitrectomy Tray
  FDA Device · Class II · 2021-11-24 · Roi Cps
  Reason: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
• REGARD Ultrasound Tray
  FDA Device · Class II · 2021-11-24 · Roi Cps
  Reason: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
• REGARD Core Biopsy Tray
  FDA Device · Class II · 2021-11-24 · Roi Cps
  Reason: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
• REGARD Newborn Tray
  FDA Device · Class II · 2021-11-24 · Roi Cps
  Reason: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
• REGARD Ear Tray
  FDA Device · Class II · 2021-11-24 · Roi Cps
  Reason: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
• REGARD Basic Cataract tray
  FDA Device · Class II · 2021-11-24 · Roi Cps
  Reason: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
• REGARD Stereotactic Tray
  FDA Device · Class II · 2021-11-24 · Roi Cps
  Reason: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
• Regard NEWBORN KIT, LD00201j, Item Number: 830016010
  FDA Device · Class II · 2021-08-11 · Roi Cps
  Reason: Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
• Regard NEWBORN KIT, LD00201M, Item Number: 830016013
  FDA Device · Class II · 2021-08-11 · Roi Cps
  Reason: Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
• Regard NEWBORN KIT, LD00201K, Item Number: 830016011
  FDA Device · Class II · 2021-08-11 · Roi Cps
  Reason: Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
• Regard Dressing Change Tray
  FDA Device · Class II · 2021-05-19 · Roi Cps
  Reason: ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
• Regard, Item Number 830067009, custom cardiovascular procedure kit
  FDA Device · Class II · 2021-04-14 · Roi Cps
  Reason: ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in…
• Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BAS…
  FDA Device · Class II · 2021-01-06 · Roi Cps
  Reason: Gauze sponges contained in custom kits may be flaking or fraying.
• Regard - Product Usage: Obstetric Gynecologic specialized manual instrument
  FDA Device · Class II · 2020-12-09 · Roi Cps
  Reason: Labeling error, incorrect expiration date.
• Isolation Droplet Bundle Kit
  FDA Device · Class II · 2020-07-08 · Roi Cps
  Reason: Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.
• Respirator Crash Cart Kit
  FDA Device · Class II · 2020-07-08 · Roi Cps
  Reason: Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.
• Regard
  FDA Device · Class II · 2020-06-17 · Roi Cps
  Reason: Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
• Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number…
  FDA Device · Class II · 2020-02-05 · Roi Cps
  Reason: ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.