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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description 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.
Recall Number Z-2089-2013
Classification Class II
Code Info Model Number (software version) 8.0.2 & 8.0.1 with RapiDispense
Product Distributed Qty 106
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.

Event Detail

Event Id 65769
Product Type Devices
Status Ongoing
City Alpharetta
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide Distribution in the states AR, MD, NJ, NY, PA, and WV.