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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira LifeCare PCA Label Utility, Version 1.0

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 Class 2 Recall
Hospira LifeCare PCA Label Utility, Version 1.0
see related information
Date Posted August 06, 2008
Recall Status1 Terminated on March 09, 2010
Recall Number Z-1181-2008
Recall Event ID 46846
Product Classification Pump, Infusion, Pca - Product Code MEA
Product Hospira LifeCare PCA Label Utility, Version 1.0 CD. The installation/user guide is entitled "LifeCare PCA Barcode Label Utility Program." This software program is designed to allow entry of each drug concentration into a formulation library on a pharmacy computer for standardized printing of barcode labels for compounded drug product vials.
Code Information Version 1.0, all CDs
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
For Additional Information Contact Mr. Robert DeRyke
224-212-2000
Manufacturer Reason
for Recall
Incorrect dosage labels created: Customers have experienced independent changes in drug concentration (mg/mL to mcg/mL and vice versa) and expiration dates, and the addition of trailing zeros to the barcodes.
FDA Determined
Cause 2
DESIGN: Software Design
Action Hospira sent letters dated 1/3/08 to the immediate recipients of the product via FedEx overnight letter on the same date. The letters informed the accounts of the reports of independent changes in drug concentration while editing a saved formulation using the Hospira LifeCare PCA Label Utility Software CD that was provided to some customers in a Hospira MedNet Drug Library Creation Team Introductory Kit-LifeCare PCA kit. The accounts were requested to remove the utility from any PC in their facility on which it is currently installed, destroy the CD and sign and return the enclosed removal verification form verifying that they have removed the software from their system. The letter listed commercially available software packages that the account could validate and implement in their facility. Any questions concerning the utility software withdrawal were directed to Hospira at 1-800-241-4002, option 4, then option 1.
Quantity in Commerce 127 CDs
Distribution Nationwide Distribution and Canada
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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