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.
Read the official notice →- Date
- 2022-06-15
- Country
- United States
- Brand
- ROi CPS
- Product
- Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
- Classification
- Class II
- Units
- Distributed to North Carolina.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-07-27
USROi 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.
- 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.
Other drugs & medical recalls in the United States
- 2022-06-15
- US
Medminder Systems, Inc. recalls MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with additional feature to…
Discontinuation of the Emergency Alert watch or pendant will no longer connect to the emergency alert system for all models. Older Model (legacy) without screen medical alert feature(button) removed
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical…
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Albania,…Official notice → - US
NeuMoDx Molecular Inc recalls NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and…
FDA · DeviceNeuMoDx Molecular IncDomestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution…Official notice → - US
Getinge Usa Sales Inc recalls Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying…
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a…
FDA · DeviceGetinge Usa Sales IncUS Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.Official notice → - US
Medacta Usa Inc recalls GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
FDA · DeviceMedacta Usa IncDistribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no…Official notice → - US
Siemens Medical Solutions USA, Inc recalls Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures…
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts…