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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 October 10, 2003
Date Posted November 27, 2003
Recall Status1 Terminated 3 on June 18, 2004
Recall Number Z-0164-04
Recall Event ID 27551
Product Classification Culture Media, For Isolation Of Pathogenic Neisseria - Product Code JTY
Product Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vitalex), microbiological media plates, Catalog #221267, packaged in cardboard carton, 100 plates per carton.
Code Information Lot/EXP 3197678/ November 13, 2003*** 3197693/ November 14, 2003*** 3198565/ November 07, 2003*** 3212853/ November 25, 2003*** 3212901/ November 27, 2003*** 3212919/ November 28, 2003*** 3212956/ December 02, 2003*** 3212972/ December 03, 2003*** 
Recalling Firm/
Manufacturer		 Becton Dickinson & Co
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact BD Customer Service
800-675-0908
Manufacturer Reason
for Recall		 Microbiological media may exhibit reduced colony size of bacteria, Haemophilus species.
FDA Determined
Cause 2		 Other
Action The recalling firm notified distributors by fax and end users by certified mail on 10/10/03. The recall notice advised consignees of reduced growth of Haemophilus species, and instructed them to discontinue distribution and use and discard product for replacement. The letter requests consignees to respond with replacement units needed.
Quantity in Commerce 7302 cartons
Distribution Product was sold to domestic distributors and direct shipped end users nationwide including government consignees, and was additionally sold to affiliated international distributors.
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.
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