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.
Recall
- Recall Number
- Z-0388-2017
- Event Number
- 75388
- Firm
- Akita Sumitomo Bakelite Co., Ltd. 27-4, Aza Nakajimita Akita Japan
- FEI Number
- 3002806337
- Product Code
- KNS
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- September 9, 2016
- Terminated
- November 10, 2016
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.
Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
Sumitomo Bakelite on September 9, 2016 initiated removal of all SB Knife from US accounts. The information was emailed to the accounts and Sumitomo Bakelite requested all customers not to use the mislabeled SB Knife and return product for replacement.
US in the states of MA
15 units