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 BD Ophthalmic

  • 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 BD Ophthalmic see related information
Date Initiated by Firm February 28, 2006
Date Posted March 15, 2006
Recall Status1 Terminated 3 on September 13, 2006
Recall Number Z-0613-06
Recall Event ID 34715
Product Classification Knife, Ophthalmic - Product Code HNN
Product BD Xstar Bevel Up Slit Knife 2.8mm , Sterile
Catalog Number: 373728
Code Information Lot Number: 5335524
Recalling Firm/
Manufacturer		 BD Opthalmic Systems
411 Waverley Oaks Road
Waltham MA 02452-8448
For Additional Information Contact David Cromwick
781-906-7916
Manufacturer Reason
for Recall		 Product labeled as a 2.8 mm may contain a 3.2 mm Xstar slit knife
FDA Determined
Cause 2		 Other
Action BD Ophthalmic notifIed customers by telephone on 2/28/06 requesting users to examine product and return mislabeled product.
Quantity in Commerce 3430 units
Distribution Nationwide Foreign: Belgium
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.
-
-