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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/
Becton Dickinson & Co.
7 Loveton Circle
Sparks MD 21152
For Additional Information Contact Becton Dickinson Regulatory Compliance
Manufacturer Reason
for Recall
Microbiological media may exhibit No Growth or reduced colony size of Haemophilus species.
FDA Determined
Cause 2
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.