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U.S. Department of Health and Human Services

Class 3 Device Recall Remel Middlebrook 7H10 Agar

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 Class 3 Device Recall Remel Middlebrook 7H10 Agarsee related information
Date Initiated by FirmMay 06, 2009
Date PostedAugust 14, 2009
Recall Status1 Terminated 3 on October 15, 2009
Recall NumberZ-1733-2009
Recall Event ID 52111
Product Classification Mycobacteria Identification Kit - Product Code JSY
ProductRemel 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
FEI Number 1924669
Recalling Firm/
Manufacturer		 Remel, Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactDebbie Wyatt
913-895-4075
Manufacturer Reason
for Recall		The plate labeling is incorrect, but the outer box labeling is correct
FDA Determined
Cause 2		Error in labeling
ActionThe 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 Commerce118 packages
DistributionNationwide Distribution -- including states of FL, NJ, IN, FL, OH, KY, TX, and WI.
Total Product Life CycleTPLC 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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