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U.S. Department of Health and Human Services

Class 2 Device Recall remel Mueller Hinton Agar w/4 NaCl w/6 mcg/ml Oxacillin

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  Class 2 Device Recall remel Mueller Hinton Agar w/4 NaCl w/6 mcg/ml Oxacillin see related information
Date Initiated by Firm December 08, 2009
Date Posted January 15, 2010
Recall Status1 Terminated 3 on July 12, 2011
Recall Number Z-0644-2010
Recall Event ID 54042
510(K)Number K850291  
Product Classification Culture media, antimicrobial susceptibility test, mueller hinton agar/broth - Product Code JTZ
Product remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenexa, KS.

The product is a solid medium recommended for use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase-resistant penicillins (PRP, e.g. methicillin, nafcillin, and oxacillin).
Code Information Lot Number 833352, Exp. 2009.12.22.
Recalling Firm/
Manufacturer		 Remel, Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Robert Booth
913-895-4007
Manufacturer Reason
for Recall		 The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm issued two different recall letters dated December 8, 2009 via regular mail. One letter was addressed to Microbiology Laboratory Supervisor and the other to Distributors. Both letters explained the reason for recall, requested the customer discard all remaining units in their possession, and complete the enclosed Product Inventory Checklist to indicate the amount of product that was discarded. The letter issued to distributors also requests they notify their customers to the laboratory level and the Product Inventory Checklist has a block to be marked indicating they have notified their customers. Direct questions to the Technical Services Department at 1-800-255-6730 (United States) or 1-913-888-0939 (International).
Quantity in Commerce 267 units
Distribution Nationwide.
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.
510(K) Database 510(K)s with Product Code = JTZ and Original Applicant = REMEL CO.
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