Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micr

FDA device recall Z-1389-2012 · posted 2012-04-09 · Terminated

Recall details

Recalling firm

Baxa Corporation

Reason for recall

Software issue with compounding pump resulting in over delivery of component ingredients during routine operations.

Action taken

Baxa sent a Safety Alert letter dated March 23, 2009 to all affected consignees. The letter identified the affected product, problem and recommended actions with specific instructions related to the issue. Additionally, the firm will be providing a warning label for the affected product as soon as possible and is currently working on a product upgrade to correct the issue. For assistance contact Baxa Technical Support at 800-678-2292. The firm is also providing a 24 hour a day, 7 days a week Technical Support for the affected product.

Root cause

Software design

Status

Terminated

Product code

NEP

Quantity affected

1322 units

Distribution

Worldwide Distribution - USA Nationwide including Canada.

Date initiated

2009-03-23

Date posted

2012-04-09

Date terminated

2012-04-10

Location

Englewood, CO