Description of Event or Problem · 1
THE COMPANY INITIATED A PRODUCT REMOVAL ON 03/03/2015 WITH CONSIGNEE NOTIFICATION OCCURRING ON 03/09/2015 PER 21 CFR 806 REQUIREMENTS DUE TO IDENTIFICATION OF THE FOLLOWING: ABSENCE OF A VALIDATION FOR THE RECOMMENDED STERILIZATION PARAMETERS FOR THE "STEAM GRAVITY 121 DEGREES C" CYCLE; THE OMISSION OF THE DRY TIME FOR THE RECOMMENDED STERILIZATION PARAMETERS FOR THE "STEAM PRE-VACUUM 132 DEGREES C" CYCLE; THESE RECOMMENDATIONS ARE FOUND ON THE IFU (INSTRUCTIONS FOR USE) AND THE INSIDE OF THE LID OF THE AFFECTED SURGICAL KITS. INITIALLY, IT WAS DETERMINED THAT MDR WAS NOT REQUIRED AS THE DECISION TO REMOVE PRODUCT WAS NOT BASED ON AN ADVERSE REACTION OR ACTUAL MALFUNCTION OF THE DEVICE. HOWEVER, AS PART OF A ROUTINE INTERNAL AUDIT AND RESULTING REVIEW OF REPORTING RESPONSIBILITIES AS FOUND IN COMMENT 12 OF "63578 FEDERAL REGISTER/VOL. 60, NO. 237/MONDAY, 12/11/1995/RULES AND REGULATIONS" MDR REPORTING WAS DETERMINED APPLICABLE TO ENSURE FULL COMPLIANCE WITH 21 CFR 803 MDR REPORTING. FOR THESE REASONS, THE DECISION TO NOT REPORT WAS REVERSED. THE COMPANY HAS NOT RECEIVED NOTIFICATION OF AN ADVERSE EVENT ASSOCIATED WITH THE AFFECTED SURGICAL INSTRUMENT KITS TO DATE. CORRECTIONS TO THE AFFECTED INSTRUMENT KITS WITH CORRECT, VALIDATED STERILIZATION PARAMETERS ARE ONGOING. THE PRODUCT IS A 510(K) EXEMPT, CLASS I DEVICE.