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 3 Device Recall

  • 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 3 Device Recall see related information
Date Initiated by Firm June 25, 2003
Date Posted August 06, 2003
Recall Status1 Terminated 3 on April 14, 2004
Recall Number Z-1076-03
Recall Event ID 26681
Product Blood Agar Plates, 5%, Lot 3155A.
Code Information Lot number A10-3155A.
Recalling Firm/
Manufacturer		 Hardy Media Inc Dba Hardy Diag
1430 West McCoy Lane
Santa Maria CA 93455
For Additional Information Contact Melissa Traylor
800-266-2222
Manufacturer Reason
for Recall		 Customers complained of bacterial contamination of lot A10-3155A.
FDA Determined
Cause 2		 Other
Action Firm conducted recall by telephone on June 25, 2003. Follow-up letter was sent within 2-3 business days. Customers were told to destroy inventory for credit or replacement.
Quantity in Commerce 11,250 plates
Distribution Nationwide.
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.
-
-