FDASeptember 9, 2016device
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 Electrosur...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type
What to do
FDA enforcement status: Terminated
Brands named
akita sumitomo bakeliteakitaakita sumitomo
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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