What is the Class I FDA recall of Digitek and Digoxin?
A Class I recall is the most serious type of recall. In a Class I recall, there is a reasonable chance that the product will cause serious health problems or death. In a Class I recall, the company: • notifies its customers (i.e. distributors or vendors), and directs them to notify the intended recipients of the device (i.e. other vendors, hospitals, nursing homes, outpatient treatment facilities, doctors, or individual patients). The notification usually contains the name of the device being recalled, identifying lot or serial numbers, the reason for the recall, and instructions about how to correct, avoid, or minimize the problem. It should also provide a telephone number for questions related to the recall. • issues a press release to notify the public, if appropriate to minimize health consequences. FDA may also issue its own press release or public health notice. FDA posts consumer information about all Class I recalls on its Medical Device Recalls website.
