Recall Z-0079-2023— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2022-09-02, terminated 2025-01-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360. Reason: 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..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-09-02
- Terminated
- 2025-01-02
- Firm location
- Mentor, OH, United States
Product description
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.