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.
FDA Recall Z-0389-2017 · Posted None
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Recalling FirmAkita Sumitomo Bakelite Co., Ltd.
Recall StatusTerminated
Product CodeKNS
Date Initiated2016-09-09
Date Terminated2016-11-10
Product Quantity8 units
Reason for Recall
Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type
Firm Action
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.
Root Cause
Error in labeling
Distribution Pattern
US in the states of MA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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