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U.S. Department of Health and Human Services

Class 2 Device Recall Oxoid CM0225 Brain Heart Infusion IVD

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  Class 2 Device Recall Oxoid CM0225 Brain Heart Infusion IVD see related information
Date Initiated by Firm December 21, 2009
Date Posted March 09, 2010
Recall Status1 Terminated 3 on July 12, 2011
Recall Number Z-0979-2010
Recall Event ID 54194
Product Classification Brain Heart Infusion IVD - Product Code JSC
Product Oxoid CM0225 Brain Heart Infusion IVD. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England.

The product is used for the cultivation of streptococci, pneumococci, meningococci and other fastidious organisms and is suitable for blood culture work.
Code Information Lot numbers 762134, Exp. 2014.04.30; 793640, Exp. 2014.07.31; and 819693, Exp. 2014.10.31
Recalling Firm/
Manufacturer		 Remel, Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Debbie Wyatt
913-895-4075
Manufacturer Reason
for Recall		 Product failure - Failure to grow quality control strains of Streptococcus pneumoniae.
FDA Determined
Cause 2		 Other
Action The recalling firm issued separate recall letters dated December 21, 2009 addressed to Microbiology Laboratory Supervisors or Distributors explaining the reason for recall and requesting all remaining product be discarded. A Product Inventory Checklist was enclosed to report the amount of product that was discarded by the customer. The Distributor letter requests the consignee contact their customers to notify them of the recall. Direct inquiries concerning this recall to the Technical Services Department at 1-800-255-6730 (United States) or 1-913-888-0939 (International).
Quantity in Commerce 105 bottles
Distribution United States (FL, NY, MO, NY, DE, and PA).
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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