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U.S. Department of Health and Human Services

Class 2 Device Recall SigmaAldrich Histopaque1119

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  Class 2 Device Recall SigmaAldrich Histopaque1119 see related information
Date Initiated by Firm December 08, 2009
Date Posted March 04, 2010
Recall Status1 Terminated 3 on April 10, 2012
Recall Number Z-0977-2010
Recall Event ID 53956
Product Classification Histopaque-1119 - Product Code JCF
Product Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and 6x100-ml. btl packages. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO.

The product is for use in separating mononuclear cells and granulocytes when used with Histopaque-1077.
Code Information Lots 038K6030, 126K6002, and 079K6047.
Recalling Firm/
Manufacturer		 Sigma-Aldrich Mfg LLC
545 S Ewing Ave
Saint Louis MO 63103-2932
For Additional Information Contact Marilyn L. Baltz, Ph.D.
314-286-6672
Manufacturer Reason
for Recall		 Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.
FDA Determined
Cause 2		 Other
Action The recalling firm issued an "Urgent Field Correction" notice dated December 7, 2009 via regular mail on December 8, 2009 which explains the reason for the field correction and instructs the user to review the enclosed, revised Instructions for Use (IFU) prior to further use of the product. The customer is requested to complete the acknowledgement information and return it to the recalling firm via FAX or e-mail. Direct questions to Sigma-Aldrich by calling 1-800-505-6275, extension 1232.
Quantity in Commerce 8,640/100-ml. btls and 3,138/6/100-ml. btl packages
Distribution Worldwide Distribution -- United States, Canada, Mexico, United Arab Emirate, Australia, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Ecuador, France, Great Britain, Hong Kong, Israel, India, Italy, Jamaica, Japan, Korea, Panama, Peru, Paraguay, Saudi Arabia, Singapore, Thailand, West Indies, Taiwan, Venezuela, and South Africa.
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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