Reason: Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. T
Distributed: US: AL, CA, FL, IL, IN, MI, MO, NY, OH, PA, TX. OUS: ITALY, GERMANY, FRANCE, GREAT BRITAIN, NETHERLANDS, WHITE RUSSIA, INDIA, JAPAN.Reason: Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. T
Distributed: US: AL, CA, FL, IL, IN, MI, MO, NY, OH, PA, TX. OUS: ITALY, GERMANY, FRANCE, GREAT BRITAIN, NETHERLANDS, WHITE RUSSIA, INDIA, JAPAN.Reason: Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250 and VITROS 350 Chemistry Systems. Increase in Software error due to affected Mixing Cup Arrays.
Distributed: Worldwide Distribution - US Nationwide and the countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, SpainReason: Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necessary disinfection and sterilization of the product. If corrosion occurs and is not detected by the user, and the device is used during surgery, corroded particles of the pin could, directly or indirect
Distributed: Worldwide Distribution - USA including CA, MN, NC, NY, OH, TX and DC. Internationally to Australia, Chile, Germany, Hungary, Italy, Panama, Qatar, Russia, Thailand, United Arab Emirates.Reason: The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.
Distributed: Distributed USA (nationwide) and the country of Canada.Reason: D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System.
Distributed: Worldwide Distribution - USA (nationwide) and Internationally to Latin America, Asia Pacific, Canada, Australia, New Zealand and India.Reason: Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
Distributed: IL MA, MN, ND, OR, & PAReason: The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings, the software could not properly calculate a purge date for the database files based on the customer data retention setting in the application. This resulted in the database files meeting its maximum capacity and causing system p
Distributed: Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IS, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and WI and the country of Canada.Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Distributed: Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Distributed: Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.