CGMP Deviations: Firm did not adequately investigate customer complaints.
All Recalls
95,114 total recalls in our database
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
Failed dissolution specifications
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
GE Healthcare Precision 500D Classical R & F system.
GE Healthcare
A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems.
Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
American Medical Systems Innovation Center - Silicon Valley
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products