ROi CPS Recalls
86 recalls on record · February 5, 2020 to February 12, 2025 · Medical Devices
Recalls by year
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25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 18, 2022Medical DevicesFDA
ROi CPS LLC recalls Regard brand CABG Pack A and B - Spartanburg
Hazard: Kits were packed into shipping boxes incorrectly.
May 4, 2022Medical DevicesFDA
ROi CPS LLC recalls Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B
Hazard: 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.
May 4, 2022Medical DevicesFDA
ROi CPS LLC recalls Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD
Hazard: 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.
May 4, 2022Medical DevicesFDA
ROi CPS LLC recalls Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD
Hazard: 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.
April 6, 2022Medical DevicesFDA
ROi CPS LLC recalls Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Hazard: Recalled devices were packaged in convenience kits.
March 9, 2022Medical DevicesFDA
ROi CPS LLC recalls Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Hazard: Products are mislabeled with the incorrect product identification on individual kit labeling.
January 19, 2022Medical DevicesFDA
ROi CPS LLC recalls Regard, T AND A - Rogers, sterilized convenience kits
Hazard: Kits lacks rubber latex warning label.
December 29, 2021Medical DevicesFDA
ROi CPS LLC recalls regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Hazard: The kit contains a non-sterile needle.
November 24, 2021Medical DevicesFDA
ROi CPS LLC recalls REGARD Vitrectomy Tray
Hazard: 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.
November 24, 2021Medical DevicesFDA
ROi CPS LLC recalls REGARD Ultrasound Tray
Hazard: 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.
November 24, 2021Medical DevicesFDA
ROi CPS LLC recalls REGARD Stereotactic Tray
Hazard: 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.
November 24, 2021Medical DevicesFDA
ROi CPS LLC recalls REGARD Newborn Tray
Hazard: 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.
November 24, 2021Medical DevicesFDA
ROi CPS LLC recalls REGARD Ear Tray
Hazard: 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.
November 24, 2021Medical DevicesFDA
ROi CPS LLC recalls REGARD Core Biopsy Tray
Hazard: 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.
November 24, 2021Medical DevicesFDA
ROi CPS LLC recalls REGARD Basic Cataract tray
Hazard: 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.
August 11, 2021Medical DevicesFDA
ROi CPS LLC recalls Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
Hazard: 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."
August 11, 2021Medical DevicesFDA
ROi CPS LLC recalls Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
Hazard: 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."
August 11, 2021Medical DevicesFDA
ROi CPS LLC recalls Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Hazard: 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."
May 19, 2021Medical DevicesFDA
ROi CPS LLC recalls Regard Dressing Change Tray
Hazard: ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
April 14, 2021Medical DevicesFDA
ROi CPS LLC recalls Regard, Item Number 830067009, custom cardiovascular procedure kit
Hazard: 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 the sterile barrier between fluid in the basin and the slush/warming equipment.
January 6, 2021Medical DevicesFDA
ROi CPS LLC recalls Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot #
Hazard: Gauze sponges contained in custom kits may be flaking or fraying.
December 9, 2020Medical DevicesFDA
ROi CPS LLC recalls Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Hazard: Labeling error, incorrect expiration date.
July 8, 2020Medical DevicesFDA
ROi CPS LLC recalls Respirator Crash Cart Kit
Hazard: 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.
July 8, 2020Medical DevicesFDA
ROi CPS LLC recalls Isolation Droplet Bundle Kit
Hazard: 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.
June 17, 2020Medical DevicesFDA
ROi CPS LLC recalls Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Hazard: Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
February 5, 2020Medical DevicesFDA
ROi CPS LLC recalls Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER -
Hazard: ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.