Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 100- and 500-ml. btls. and a 6x100-ml. bottle package. The firm n

FDA device recall Z-0976-2010 · posted 2010-03-04 · Terminated

Recall details

Recalling firm

Sigma-Aldrich Mfg LLC

Reason for recall

Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.

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.

Root cause

Other

Status

Terminated

Product code

JCF

Quantity affected

11,015/100-ml. btls; 5,745/6/100-ml btl packages; and 14,872/500-ml. btls.

Distribution

Worldwide Distribution -- United States, Canada, Mexico, United Arab Emirate, Australia, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Ecuador, France, Great Britai

Date initiated

2009-12-08

Date posted

2010-03-04

Date terminated

2012-04-10

Location

Saint Louis, MO