ROBOTIC/ LAPAROSCOPY KITTNER ROLLS MEDIUM 4" LONG 5PK 25PKS

Additional Manufacturer Narrative

LOT 1657 WAS NOT PREVIOUSLY IDENTIFIED AS PART OF THE ONGOING VOLUNTARY RECALL. HOWEVER, THIS NEW COMPLAINT ALIGNS WITH THE SAME FAILURE MODE DESCRIBED IN CAPA-2025-01. GIVEN THE RECURRENCE OF THIS ISSUE IN A LOT THAT WAS PREVIOUSLY INSPECTED, WE ARE TREATING THIS AS A SIGNIFICANT EVENT. CAREFREE WILL INITIATE A VOLUNTARY NOTIFICATION AND RECALL FOR LOT 1657 AS A PROACTIVE MEASURE UNDER CAPA-2025-04.

Description of Event or Problem

CUSTOMER EXPERIENCED A PRODUCT FAILURE WITH THE KITTNER ROLL GAUZE AND QUARANTINED THE AFFECTED PACKAGE. THEY HAD 1 PK THAT ONLY HAD 4 EA. LOT# 1657. OR MATERIALS TEAM HAS ALREADY CHECKED OUR SHELVES FOR ANY ADDITIONAL PRODUCT, WHICH WAS NOT IDENTIFIED. PRODUCT IS AVAILABLE FOR RETURN.