Z-1060-2014 Class I Terminated

Recalled by MCKESSON TECHNOLOGIES INC. — Durham, NC

Recall Details

Product Type
Devices
Report Date
March 12, 2014
Initiation Date
March 15, 2013
Termination Date
May 1, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10

Product Description

McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.

Reason for Recall

There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case.

Distribution Pattern

Nationwide Distribution including CA, GA, IN, KY, MD, MI, OH, OK, and WA.

Code Information

MAC 14.3.1/MAC 14.3.1.1