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 Fischer Cone Biopsy Excisor

  • 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 Fischer Cone Biopsy Excisorsee related information
Date Initiated by FirmMarch 12, 2018
Create DateMay 15, 2018
Recall Status1 Terminated 3 on May 08, 2019
Recall NumberZ-1879-2018
Recall Event ID 79828
510(K)NumberK061651 
Product Classification Electrocautery, gynecologic (and accessories) - Product Code HGI
ProductFischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
Code Information Lot number: 212074
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information ContactCustomer Service
203-601-9818
Manufacturer Reason
for Recall		Products have been packaged with an incorrect product size.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn March 26, 2018 CooperSurgical mailed medical device recall notification letters to affected customers. Customers were instructed to: please discontinue use of any of the lots listed in the table above and complete the attached Acknowledgement and Receipt Form to schedule refund or exchange. If you have supplied or transferred any potentially affected product to another facility or organization, please let them know of the recall by providing a copy of this letter. If you have any further questions, please feel free to contact CooperSurgical at recall@coopersurgical.com.
Quantity in Commerce500
DistributionCA, SC, WI, MI, NH, MD, OH, NJ, Australia, France, Spain
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HGI
-
-