AESCULAP

Additional Manufacturer Narrative

DHR AND RETENTION SAMPLES ARE NOT ABLE TO BE REVIEWED WITHOUT LOT CODE INFORMATION. SAMPLES WERE RETURNED, 4 OUT OF THE 5 WERE POST-STERILIZATION. THE ONE THAT WAS PRE-STERILIZATION SHOWED A WEAK SPOT NOT A PINHOLE. THE RAW MATERIAL SUPPLIER IS ISO 13485 CERTIFIED SUPPLIER FOR STERILIZATION PACKAGING AND INFECTION CONTROL MATERIAL AND TESTS EACH LOT OF THIS FILTER MATERIAL FOR POROSITY, PERMEABILITY, AND WATER REPELLENCY. REVIEW OF PRODUCT REQUIREMENTS ARE ONGOING BY BOTH AESCULAP AND HU-FRIEDY'S TECHNICAL TEAMS. COMPLAINT WILL BE CLOSED AS NOT CONFIRMED.

Description of Event or Problem

DISTRIBUTOR STATED CUSTOMER REPORTED THAT FILTERS HAVE BEEN NOTED TO HAVE PIN PRICK HOLES IN THE FILTERS. THE LOT IS NOT KNOWN AS IT IS UNCLEAR WHEN THE PROCESSING OF THE DEVICES OCCURRED - LOT THEREFORE CANNOT BE DETERMINED BASED ON STOCK.