Reason: The RITA Main Cable product contains the incorrect Instructions for Use.
Distributed: Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.Reason: Cassette may leak during set up or during peritoneal dialysis treatment
Distributed: Nationwide DistributionReason: Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
Distributed: Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.Reason: Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
Distributed: Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.Reason: Product labeled with incorrect expiration date.
Distributed: Worldwide Distribution - USA Nationwide including the state of NY, NE, MD, OH, TX, PA, VA, PR, CA, NJ, NY, CA and the countries of: AT, FR, DE, GB, IL, IT, LB, NL, ES, SE, TN, Argentina, and Japan.Reason: Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory Notice to all customers who use the AMO Sovereign¿ Compact Phacoemulsification System, Version 5.3, because it has the potential to lose the vacuum tone mode during surgery.
Distributed: Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.Reason: Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.
Distributed: Nationwide DistributionReason: Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin.
Distributed: Worldwide distribution: US (nationwide) distribution: Algeria, Argentina, Australia, Bahamas, Bahrain, Bermuda, Boliva, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Southern Territories, Germany, Great Britain, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Netherlands, Norway, New Zealand, Oman, Panama, Paraguay, Peru, Poland, Province of China, Taiwan, Qatar, Republic of Korea, Romania, Russia Federation, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, Uruguay, and¿Venezuela.Reason: The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
Distributed: Distributed in KY and AL.Reason: Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also heated after a few seconds or more. This occurs when the Automatic Exposure Function (AEC) function is used. As a result, a radiographic tube current exceeding the set value flows and a brighter image than expected is acquired.
Distributed: US Nationwide Distribution