VISTEC

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR LOT 25D014362 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SAMPLES WERE RECEIVED FOR EVALUATION AND THE REPORTED ISSUE WAS OBSERVED. THE MOST PROBABLE ROOT CAUSE IS POOR HANDLING AND PACKING DURING THE MANUAL PACKAGING PROCESS. THE PRODUCTION LINE SUPERVISOR WAS NOTIFIED OF THIS ISSUE, AND QUALITY AWARENESS TRAINING WAS COMMUNICATED TO THE NECESSARY PRODUCTION PERSONNEL. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR REPORTS AND TAKE ACTIONS AS APPLICABLE.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE PRODUCT IS AFFECTED BY THE PACKAGING STATING THAT THEY ARE FRAYING, SOME DON'T HAVE THE PAPER STRIP AROUND THE PACK OF 10 AND A FEW ARE STICKING TO THE PAPER WHEN TRYING TO OPEN. ADDITIONAL INFORMATION RECEIVED ON 18SEP2025 STATED THAT THE FRAYING IS FROM THE ACTUAL GAUZE.