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Terminated

Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures.

FDA Recall Z-2089-2013 · Posted 2013-08-26

Recall StatusTerminated
Product CodeBRY
Date Initiated2013-07-22
Date Terminated2014-06-19
Product Quantity106

Reason for Recall

The firm issued a clinical alert after users reported an issue where the Anesthesia-Rx system was interrupted ANF became temporarily unavailable during use.

Firm Action

McKesson sent a Clinical Alert letter dated July 22, 2013 to all affected customers. The letter identified the affected product, symptoms, and actions to be taken. McKesson committed to releasing 8.0.2 Update 1.5 to affected customers which will include enhanced code to prevent the unhandled excpetion errors. Additional resolution steps were included in the letter. For questions call 1-800-700-8737.

Root Cause

Software design

Distribution Pattern

USA Nationwide Distribution in the states AR, MD, NJ, NY, PA, and WV.

Official Source

View FDA Recall →

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

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