PlainRecordsFDA · Medical device recall
SB Knife -Electrosurgical Knife… and 1 more product
- Date
- Nov. 16, 2016
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Akita Sumitomo Bakelite Co., Ltd.
- Distribution pattern
- US in the states of MA
2 products in this recall
SB Knife -Electrosurgical Knife…
- Product
- 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
- Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
- Quantity
- 15 units
- Codes and lots
- Lot No.: 60564711
- Recall started
- Sept. 9, 2016
- Device type
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Root cause (FDA)
- Error in labeling
- What the company told customers
- 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.
- Recall number
- Z-0388-2017
SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm…
- Product
- 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.
- Reason
- Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type
- Quantity
- 8 units
- Codes and lots
- Lot No.: 60564713
- Recall started
- Sept. 9, 2016
- Device type
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Root cause (FDA)
- Error in labeling
- What the company told customers
- 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.
- Recall number
- Z-0389-2017
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0388-2017, Z-0389-2017. The agency record governs; check it and the company before acting.