Recall Z-0977-2010
Sigma-Aldrich Mfg LLC · initiated December 8, 2009
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.
Codes / lots: Lots 038K6030, 126K6002, and 079K6047.
Reason for recall
Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0977-2010
- Initiated
- December 8, 2009
- Posted by FDA
- March 4, 2010
- Terminated
- April 10, 2012
- Product code
- JCF – Lymphocyte Separation Medium
- Quantity
- 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.
- Recalling firm
- Sigma-Aldrich Mfg LLC, Saint Louis, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0976-2010 | Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 100- and 500-ml. btls. and a…Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain… | 12/08/2009Terminated |