Recall Z-0388-2017— Akita Sumitomo Bakelite Co., Ltd.
Class II · Terminated
Class II FDA medical device recall by Akita Sumitomo Bakelite Co., Ltd., initiated 2016-09-09, terminated 2016-11-10. It names one FDA 510(k) clearance: K152771. 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.. Reason: Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long.
- Recalling firm
- Akita Sumitomo Bakelite Co., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-09
- Terminated
- 2016-11-10
- Firm location
- Akita, Japan
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
Data sourced from openFDA. This site is unofficial and independent of the FDA.