Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CUTTING ELECTRODE BIPO

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall CUTTING ELECTRODE BIPO see related information
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.
-
-