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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm November 18, 2002
Date Posted December 18, 2002
Recall Status1 Terminated 3 on May 01, 2003
Recall Number Z-0345-03
Recall Event ID 25158
Product Classification Culture Media, For Isolation Of Pathogenic Neisseria - Product Code JTY
Product Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media plates.
Catalog # 221267
Code Information Lots: 2213201 EXP 11/25/02 2213211 EXP 11/26/02 2261524 EXP 1/14/02 2246310 EXP 1/1/03 2261552 EXP 1/15/03 2276445 EXP 1/29/03
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Circle
Sparks MD 21152
For Additional Information Contact Becton Dickinson Regulatory Compliance
410-316-4258
Manufacturer Reason
for Recall		 Microbiological media may exhibit No Growth or reduced colony size of Haemophilus species.
FDA Determined
Cause 2		 Other
Action Becton Dickinson notified distributors by fax on 11/18/02 to discard inventory. Firm additionally notified distributors on 11/21/02 to include three additional lots of agar for recall. End users were notified by letter 11/21/02 to discard inventory for replacement, and return reply form.
Quantity in Commerce 6422 cartons/ 100 plates per carton
Distribution Product was sold to distributors and subsequently distributed to medical facility end users nationwide and internationally.
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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