Reported Nov 16, 2016 · Terminated
SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB…
Akita Sumitomo Bakelite Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akita Sumitomo Bakelite Co., Ltd. · 27-4, Aza Nakajimita · Akita · N/A
Is this the product you have?
- SB (Sumitomo Bakelite Co.,)
- Electrosurgical Knife SizeWorking Length 1.8M Maximum OD 2.6mm
- Product UsageThe SB Knife is a single-use sterile
- Electrosurgical Knife (Model NumbersMD-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
- Lot codes and dates
- Lot No.: 60564713
- Amount recalled
- 8 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type
This product could cause temporary or reversible health problems — stop using it.
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