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U.S. Department of Health and Human Services

Class 3 Device Recall

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  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/
Hardy Media Inc Dba Hardy Diag
1430 West McCoy Lane
Santa Maria CA 93455
For Additional Information Contact Melissa Traylor
Manufacturer Reason
for Recall
Customers complained of bacterial contamination of lot A10-3155A.
FDA Determined
Cause 2
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.