| Date Initiated by Firm | June 25, 2021 |
|---|
| Create Date | August 12, 2021 |
|---|
| Recall Status1 |
Terminated 3 on January 05, 2024 |
| Recall Number | Z-2246-2021 |
|---|
| Recall Event ID |
88249 |
| 510(K)Number | K062720 |
|---|
| Product Classification |
Resectoscope - Product Code FJL
|
| Product | CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323 |
|---|
| Code Information |
Lot Number 21002858 |
| FEI Number |
3002808001
|
Recalling Firm/
Manufacturer |
Richard Wolf GmbH
Pforzheimer Str. 32
Knittlingen Germany
|
Manufacturer Reason
for Recall | Product labeled as Cutting Electrode may contain BIVAP electrode. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | The firm notified its importer 06/25/2021 and subsequently initiated the recall by letter (titled URGENT SAFETY INFORMATION) to its consignees on 06/29/2021. The letter explained the issue and the hazard, and requested consignees and user facilities scrap the affected device. |
|---|
| Quantity in Commerce | 20 boxes |
|---|
| Distribution | US Nationwide Distribution in the states of CA, CO, IN, MA, NH |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = FJL
|
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