Drug, Equipment, Medical Devices, and Other Recalls


 
POLICY:
 
In the event of a drug recall, (which includes medications dispensed by the organization, and 
vaccines), or blood and blood products, medical devices, 
equipment, supplies or food it is the responsibility of the 
Medical Director in coordination with the appropriate staff 
members to discern if the identified recalled product is 
contained within the facility.  Once it has been determined 
the product is part of the organization's medication system, 
equipment inventory, supplies, food, blood or blood products, 
etc, the following will occur:
 
PROCEDURE:
 
Within 24 hours after the receipt of recall notice from a 
manufacturer, FDA, CDC, State, Federal or other reputable 
sources, such as medical suppliers the recalled product(s) 
will be removed from the location(s) within the facility by 
appropriate staff.
 
If the product was utilized on a patient or dispensed to a 
patient, notification of patients as appropriate will also 
commence by various means; i.e. telephone calls, email, or 
U.S. mail.
 
The recalled product will be returned to the appropriate 
organization or department as determined by the manufacturer, 
FDA, CDC, etc.  The return process will follow all specified 
directions regarding packaging, shipping, and tracking. 
 
Notification of all recalls shall be kept for a 
period of at least one (1) year and will contain documentation of actions
 and results.


Approved By Governing Board    
MP.3    
Control #246.2
GUPTA GASTRO