SB Electrosurgical Knife Size: Working Length 1 recalled over labeling errors

Recall date

September 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Akita Sumitomo Bakelite Co., Ltd. recalls SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Kni…

Recall number

Z-0389-2017

FDA classification

Class II

Brand / firm

Akita Sumitomo Bakelite Co., Ltd.

Sold / distributed

US in the states of MA

Why it was recalled

Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M 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.