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Terminated

Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities. Product Usage: Pharmacy compounding System for parenteral macro and micro ingredients

FDA Recall Z-1389-2012 · Posted 2012-04-09

Recalling FirmBaxa Corporation
Recall StatusTerminated
Product CodeNEP
Date Initiated2009-03-23
Date Terminated2012-04-10
Product Quantity1322 units

Reason for Recall

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

Firm Action

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

Distribution Pattern

Worldwide Distribution - USA Nationwide including Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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