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.
Read the official notice →- Date
- 2022-07-27
- Country
- United States
- Brand
- ROi CPS
- Product
- Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
- Classification
- Class II
- Units
- Distribution was made to MO. There was no foreign/military/government…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More ROi CPS recalls
- 2023-10-11
USROi 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.
- 2022-07-06
- 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.
Other drugs & medical recalls in the United States
- 2022-07-27
- US
Baxter Healthcare Corporation recalls Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - US
Aesculap Implant Systems LLC recalls MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
- US
Aesculap Implant Systems LLC recalls Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
- US
Aesculap Implant Systems LLC recalls RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Customized coronal rod benders may deform the implant when used with the spinal system devices.
- US
Xstrahl Limited recalls X80 RADiant Photoelectric Therapy System
There is a potential compatibility issue with the systems and replacement treatment applicators.
- US
RAYSEARCH LABORATORIES AB recalls RayStation 9B SP1. For radiation treatment planning.
An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.
FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide distribution - US Nationwide distribution in the state of TN and the…Official notice →