ROi CPS recalls
20 official recalls and safety alerts involving ROi CPS since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with ROi CPS or the relevant agency.
- 2025-02-12
USROi CPS LLC recalls regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor…
There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends…
FDA · DeviceROi CPS LLCDistribution was made to MO. There was no government/military/foreign…Official notice →- 2024-09-25
- US
ROi CPS LLC recalls regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
- 2024-08-28
- US
ROi CPS LLC recalls Regard Kit containing the Microtek decanter
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
- 2024-01-24
- US
ROi CPS LLC recalls regard Operative LAP, Item Number 800943001; surgical convenience kit
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
- 2024-01-10
- US
ROi CPS LLC recalls Regard Dressing change kit, Item Number 800026006
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
- 2023-11-22
- US
ROi CPS LLC recalls Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of…
- 2023-10-11
- US
ROi CPS LLC recalls GS0008 2Y - Burn Pack - STL, Item Number 880082025
Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.
- 2023-05-03
- US
ROi CPS LLC recalls Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
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.
FDA · DeviceROi CPS LLCUS Nationwide distribution in the states of FL and MO. There was no…Official notice → - 2022-11-30
- US
ROi CPS LLC recalls regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
- 2022-07-27
- US
ROi CPS LLC recalls Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
FDA · DeviceROi CPS LLCDistribution was made to MO. There was no foreign/military/government…Official notice → - 2022-07-06
- US
ROi CPS LLC recalls regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
A nonsterile component was packaged in a sterile convenience kit.
- 2022-06-15
- US
ROi CPS LLC recalls regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.
- US
ROi CPS LLC recalls Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
Potential for the tip of the electrode to detach during use.
- 2022-05-18
- US
ROi CPS LLC recalls Regard brand CABG Pack A and B - Spartanburg
Kits were packed into shipping boxes incorrectly.
- 2022-05-04
- US
ROi CPS LLC recalls Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery…
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.
- 2022-04-06
- US
ROi CPS LLC recalls Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Recalled devices were packaged in convenience kits.
- 2022-03-09
- US
ROi CPS LLC recalls Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Products are mislabeled with the incorrect product identification on individual kit labeling.
- 2022-01-19
- US
ROi CPS LLC recalls Regard, T AND A - Rogers, sterilized convenience kits
Kits lacks rubber latex warning label.
- 2021-12-29
- US
ROi CPS LLC recalls regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
The kit contains a non-sterile needle.
FDA · DeviceROi CPS LLCDistribution was made to Missouri. There was no foreign/military/government…Official notice → - 2021-11-24
- US
ROi CPS LLC recalls REGARD Vitrectomy Tray
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.