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 |
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 and Original Applicant = RICHARD WOLF MEDICAL INSTRUMENTS CORP.
|