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U.S. Department of Health and Human Services

Class 3 Device Recall Genairex

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  Class 3 Device Recall Genairex see related information
Date Initiated by Firm August 16, 2010
Date Posted September 17, 2010
Recall Status1 Terminated 3 on January 24, 2011
Recall Number Z-2427-2010
Recall Event ID 56564
Product Classification Bag, Stomal - Product Code GDS
Product Genairex Securi-T Ostomy Deodorant
(8 oz, 1 oz package sizes)
Code Information Securi-T Ostomy Deodorant, 8 oz  Part # 108000, UPS Code 81164000810 Lots: E10051
Recalling Firm/
Manufacturer		 BioMed Laboratories
2414 Executive Dr # 102
Garland TX 75041-6123
For Additional Information Contact Greg White
972-989-7646
Manufacturer Reason
for Recall		 The product may contain the mold Aspergillus ssp.
FDA Determined
Cause 2		 Material/Component Contamination
Action Biomed Laboratories, Inc. of Garland, TX is conducting a recall of the Reliamed Odor Eliminator Drops, Securi-T Ostomy Deodorant, and the Safe n' Simple (Sn'S) Ostomy Appliance Deodorant. Lots being recalled were distributed between June 9, 2009 though June 28, 2010. Biomed will work with their 3 consignees to inform sub-distributors and down to any firm that keeps the product in stock to have the product removed from further distribution and returned. If there are any questions or concerns, please contact Biomed Laboratories, Inc. at (972) 282-8008 or email them at biomedlabs.net.
Quantity in Commerce 16,234 (15,054 8oz bottles. 1,180 1oz bottles).
Distribution OH, FL, MI
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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