Coapt LLC recalls Coapt Dome Electrode, Gen2 system, cutaneous electrode
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Read the official notice →- Date
- 2023-11-08
- Country
- United States
- Brand
- Coapt LLC
- Product
- Coapt Dome Electrode, Gen2 system, cutaneous electrode
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the country of Sweden.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
Other drugs & medical recalls in the United States
- 2023-11-08
USNova Biomedical Corporation recalls Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and…
Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge…
FDA · DeviceNova Biomedical CorporationNationwide Foreign: Country Algeria Australia Austria Bangladesh Benin Bolivia…Official notice →- US
RAYSEARCH LABORATORIES AB recalls RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical…
An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with…
- US
Smiths Medical ASD Inc. recalls Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).
FDA · DeviceSmiths Medical ASD Inc.Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH,…Official notice → - US
Randox Laboratories Ltd. recalls RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature…
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution including Puerto RicoOfficial notice → - US
Quest Medical, Inc. recalls Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV…
For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a…
FDA · DeviceQuest Medical, Inc.US:TX, UT, FL, CA, VA, CO, AL, NV, IL, OK, OH, PA, MO, MN, MT, WA, MI, TN, NY…Official notice → - US
Siemens Medical Solutions USA, Inc recalls ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and…
Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure