SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Produc...
FDA Device Recall #Z-0388-2017 — Class II — September 9, 2016
Recall Summary
| Recall Number | Z-0388-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 9, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Akita Sumitomo Bakelite Co., Ltd. |
| Location | Akita |
| Product Type | Devices |
| Quantity | 15 units |
Product 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.
Reason for Recall
Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
Distribution Pattern
US in the states of MA
Lot / Code Information
Lot No.: 60564711
Other Recalls from Akita Sumitomo Bakelite Co., Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0389-2017 | Class II | SB (Sumitomo Bakelite Co.,) Electrosurgical Kni... | Sep 9, 2016 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.