04
Sep
2009

Cl Il Hospira Phoenix Infusion System

,
0

Company:Hospira Inc.
Date of Enforcement Report 9/2/2009
Class:ll

PRODUCT
1) Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Recall # Z-1815-2009;

2) Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0, Recall # Z-1816-2009

REASON
Potential delay/under infusion of critical therapy– Devices experience increased frequency of alarms that result in temporary pump stoppage.

RECALLING FIRM/MANUFACTURER
Hospira, Inc., Morgan Hill, CA, by letter dated March 31, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
12,222 Units

DISTRIBUTION
Nationwide

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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