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Class 3 Device Recall Remel Middlebrook 7H10 Agar |
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Date Initiated by Firm |
May 06, 2009 |
Date Posted |
August 14, 2009 |
Recall Status1 |
Terminated 3 on October 15, 2009 |
Recall Number |
Z-1733-2009 |
Recall Event ID |
52111 |
Product Classification |
Mycobacteria Identification Kit - Product Code JSY
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Product |
Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel, Lenexa, KS.
Solid Medium recommended for use in qualitative procedures for the isolation and cultivation of mycobacteria. |
Code Information |
Lot 763654, Exp. 2009.07.07 |
Recalling Firm/ Manufacturer |
Remel, Inc 12076 Santa Fe Trail Dr Lenexa KS 66215-3519
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For Additional Information Contact |
Debbie Wyatt 913-895-4075
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Manufacturer Reason for Recall |
The plate labeling is incorrect, but the outer box labeling is correct
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FDA Determined Cause 2 |
Error in labeling |
Action |
The recalling firm issued Important Medical Device Customer Recall Notice letters dated 5/6/08 via regular mail explaining the reason for recall and requesting all remaining inventory of the recalled lot be discarded. A Product Inventory Checklist was enclosed for completion to report the amount of inventory destroyed. A self-addressed postage-paid envelope was enclosed for return of the Product Inventory Checklist. Customers are to contact the firm's Technical Services Department at 800-447-3641 if they have inquiries concerning the letter. |
Quantity in Commerce |
118 packages |
Distribution |
Nationwide Distribution -- including states of FL, NJ, IN, FL, OH, KY, TX, and WI. |
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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