Home / Recalls / Medical Devices
Akita Sumitomo Bakelite Co., Ltd. recalls SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife
Recalled November 16, 2016 · FDA recall Z-0388-2017 · Akita Sumitomo Bakelite
Hazard
Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long · FDA Class II
Units
15 units
Sold at
US in the states of MA
Description
Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
Product
SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
Manufacturer(s)
Akita Sumitomo Bakelite Co., Ltd.
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →