Millar Instruments, Inc, and the U.S. Food and Drug Administration (FDA) issued a recall of Human Use High Injection Angiographic Catheter, Models SPC-454D and SPC-454F today. This is a Class I recall which means that this recall represents a situation in which there is a reasonable probability that the use of or exposure to a […]
Millar Instruments, Inc, and the U.S. Food and Drug Administration (FDA) issued a recall of <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">Human Use High Injection Angiographic Catheter, Models SPC-454D and SPC-454F today.
This is a Class I recall which means that this recall represents a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class I is the most serious FDA recall designation.
The Mikro-Tip Angiographic Catheter recall was initiated because there exists the potential for small particles—debris—to be found within the catheter. This foreign debris can potentially travel—embolize—from the catheter and into patient tissues, blood vessels, limbs, and organs, which could lead to a decreased blood supply to these structures, which can result in serious injury and/or death.
This medical device measures pressure within the blood vessels and is capable of delivering high-speed injection of material that is not absorbed into the body, such as radiopaque contrast media, which is then used to view blood vessels. A total of 965 Catheters of SPC-454D and 454F were distributed to Millar international distributors and 115 catheters were distributed to Millar customers in seven states: California, the District of Columbia, Massachusetts, Michigan, Minnesota, New York, and Pennsylvania.
Customers can arrange for return of all recalled products. Millar Instruments can be reached, toll-free, at 1.800.669.2343.
Healthcare professionals and patients are encouraged by the FDA to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download the form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm or call 1.800.332.1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
