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

Additional Manufacturer Narrative

CUSTOMER REPORTED INCORRECT QUANTITY IN SKU 15505/25 LOT 1645. PACKAGE LABELED AS 5 PACK CONTAINED 6 UNITS. THE PRODUCT WAS NOT USED, AND NO PATIENT CONTACT OCCURED. ROOT CAUSE DETERMINED TO BE OPERATOR OVERSIGHT DURING FINAL PACKAGING. STAFF WAS RETRAINED AND ADDIONAL PACKAGING CHECKS IMPLEMENTED. A REPLACEMENT PRODUCT WAS SENT. DEVICE WAS NOT RETURNED FOR EVALUATION. A VOLUNTARY RECALL WILL BE INITIATED IN JULY 2025.

Description of Event or Problem

A RECENT PACK OF KITTNER ROLLS, SKU 15505/25 OPENED IN SURGERY WAS FOUND TO HAVE 6 ROLLS INSTEAD OF 5. THE OR STAFF DECIDED NOT TO USE THAT ONE DURING SURGERY INCASE THERE WAS A DEFECT. THE OUTSIDE PACKAGING WAS DISCARDED SO THE LOT NUMBER WAS NOT AVAILABLE.