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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmJune 25, 2003
Date PostedAugust 06, 2003
Recall Status1 Terminated 3 on April 14, 2004
Recall NumberZ-1076-03
Recall Event ID 26681
ProductBlood Agar Plates, 5%, Lot 3155A.
Code Information Lot number A10-3155A.
FEI Number 2022807
Recalling Firm/
Manufacturer		 Hardy Media Inc Dba Hardy Diag
1430 West McCoy Lane
Santa Maria CA 93455
For Additional Information ContactMelissa Traylor
800-266-2222
Manufacturer Reason
for Recall		Customers complained of bacterial contamination of lot A10-3155A.
FDA Determined
Cause 2		Other
ActionFirm 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 Commerce11,250 plates
DistributionNationwide.
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.
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