Drug recall
SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB…
FDA recall event 75388 · Class II · Akita Sumitomo Bakelite Co., Ltd.
Key facts
| Event ID | 75388 |
|---|---|
| Recall numbers | Z-0388-2017, Z-0389-2017 |
| Recalling firm | Akita Sumitomo Bakelite Co., Ltd. |
| Product type | Devices |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long, Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type |
| Initiation date | Sep 9, 2016 |
| Report date | Nov 16, 2016 |
| Termination date | Nov 10, 2016 |
| City | Akita |
| Country | Japan |
| FEI number | 3002806337 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: