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 |
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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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