• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall BD Beaver

  • 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 Beaver see related information
Date Posted February 08, 2007
Recall Status1 Terminated on March 07, 2016
Recall Number Z-0403-2007
Recall Event ID 37057
Product Classification manual surgical instrument - Product Code HNN
Product BD Beaver¿ Mini-Blade, Blade Sharp Two Sides Pointed, Catalog Number: 376300
Code Information Lot Number: 6159927
Recalling Firm/
Becton Dickinson and Company
411 Waverley Oaks Rd Ste 2229
Waltham MA 02452-8448
For Additional Information Contact David Cromwick
Manufacturer Reason
for Recall
Product sterility may be compromised due to incomplete package seal
FDA Determined
Cause 2
Action On 12/26/2006 BD Medical, Ophthalmic Systems mailed a recall notification letter to US Distributors and US OEM''s. Customers are instructed to return any affected products to BD for a replacement. On 1/10/07, the firm expanded the recall to additional lots. Those lots are noted with an asterisk.
Quantity in Commerce 2,934 units
Distribution Worldwide, including USA, Asia, Australia, Canada, Mexico, Taiwan, Singapore, Korea, and Japan.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.