Z-0389-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 16, 2016
- Initiation Date
- September 9, 2016
- Termination Date
- November 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
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.
Reason for Recall
Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type
Distribution Pattern
US in the states of MA
Code Information
Lot No.: 60564713