Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on the label is Sigma-Aldrich, Inc.,

FDA device recall Z-0974-2010 · posted 2010-03-04 · Terminated

Recall details

Recalling firm

Sigma-Aldrich Mfg LLC

Reason for recall

Some of the product was contaminated with Pseudomonas mendocina

Action taken

An "IMPORTANT PRODUCT NOTIFICATION" dated September 4, 2009 was sent to customers via regular mail. The notification letter described product, problem and action to be taken. The customers were requested to immediately discontinue use of the product and discard all remaining material. Subrecall was requested if the product was further distributed. The customer is to complete and fax the notification form to (314) 286-7829 to assure proper replacement for material they have not used and which is to be discarded. Should you have any questions, please contact Signma-Aldrich Technical Service at (800) 325-5832.

Root cause

Other

Status

Terminated

Product code

JCF

Quantity affected

6,808/500-ml. bottles

Distribution

Worldwide distribution: USA and Great Britain, France, China, Germany, Australia, Canada, Mexico, Korea, Singapore, India, Japan, Colombia, Hong Kong, Peru, Taiwan, and Venezuela.

Date initiated

2009-09-04

Date posted

2010-03-04

Date terminated

2012-04-10

Location

Saint Louis, MO