Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
- Company
- Steris Corporation
- Recall Initiated
- September 2, 2022
- Posted
- October 12, 2022
- Terminated
- January 2, 2025
- Recall Number
- Z-0079-2023
- Quantity
- 5 US; 62 OUS
- Firm Location
- Mentor, OH
Reason for Recall
The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking hazard.
Distribution
Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India.
Lot / Code Info
UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621
Root Cause
Process design
Action Taken
Starting September 2, 2022, Hu-Friedy notified all affected customers and distributors via Urgent Medical Device Recall letters. Customers were instructed to immediately destroy all on-hand inventory of the affected lots of K360 Scalpel Handles. Distributors should identify and notify any of their customers who have received further distributed product. Hu-Friedy will issue credit upon receipt of completed response forms.