Recall Z-0388-2017 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Akita Sumitomo Bakelite Co., Ltd.
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 tra
| Date | Sep 9, 2016 |
| Status | Terminated |
| Reason | Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long |
| Root cause | Error in labeling |
| 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. |
| Quantity | 15 units |
| Distribution | US in the states of MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152771 | SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long Sumitomo Bakelite Co., Ltd., Jun 17, 2016 |