Steris Corporation: Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360

Hazard

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.

Details from the source

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. Quantity: 5 US; 62 OUS Lot/code info: UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621

UPC codes

10889950014193

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.