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 Bard Dimension Stone Basket

  • 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 Bard Dimension Stone Basket see related information
Date Initiated by Firm December 22, 2003
Date Posted January 09, 2004
Recall Status1 Terminated 3 on September 01, 2004
Recall Number Z-0314-04
Recall Event ID 28010
Product Classification Dislodger, Stone, Basket, Ureteral, Metal - Product Code FFL
Product Bard¿ Dimension¿ Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014
Code Information Catalog numbers: 042310, 042313, 042316, 043310, 043313, 043316, 045215, 045290, 045315, 045390 and 045490.
Recalling Firm/
Manufacturer		 C.R. Bard, Inc., Urological Division
8195 Industrial Blvd Ne
Covington GA 30014-1497
For Additional Information Contact Frances E. Harrison
770-784-6257
Manufacturer Reason
for Recall		 Product packaging may contain holes compromising sterility.
FDA Determined
Cause 2		 Other
Action Consignees were notified by certified letter on 12/22/2003.
Quantity in Commerce 12,684 units (total includes both types)
Distribution Product was distributed Nationwide, Canada, Belgium and Japan
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.
-
-