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Akita Sumitomo Bakelite Co.

2 recalls •
🏥 Medical Devices
• Categories: Surgical Instruments

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.

Class I - Dangerous

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

Sep 9, 2016 Surgical Instruments View Details →

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.

Class I - Dangerous

Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long

Sep 9, 2016 Surgical Instruments View Details →