Compounding Brochure titled ''Nutrition Compounding Simplified'', Lit #800415, print date January 2002; the brochure is

FDA device recall Z-0988-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

The promotional material for the Automix/Accusource and Micromix compounders and Micromix Compounder Implementation Guide contain an incomplete accuracy statement regarding the delivery of each ingredient by the compounders.

Action taken

Baxter sent Important Product Information letters dated 4/30/04 to all of the compounder customers, informing them of the inaccurate information and requesting that the Nutrition Compounding Simplified brochure, Baxter Info Quick Cards on CD-Rom, versions Q4 2003 and Q2 2003, and pages 60 and 61 of the Micromix Compounder Implementation Guide be destroyed. Replacement pages 60 and 61 of the implementation guide were enclosed with the letter. The letters also listed the accuracy information for each compounder based on Baxter''s supporting data, as well as the specific information regarding the overdelivery alarm limits referenced in the Operator''s Manuals.

Root cause

Other

Status

Terminated

Product code

LHI

Quantity affected

1,366 units

Distribution

Nationwide, United Kingdom, Germany, Chile, Canada, Brazil, El Salvador, Taiwan, Korea, Italy, Saudi Arabia, Israel, China, Indonesia, Hong Kong, Colombia, Argentina, Mexico, Guatemala, Costa Rica, Pa

Date initiated

2004-04-30

Date posted

2004-07-20

Date terminated

2006-04-21

Location

Round Lake, IL