Hospira LifeCare PCA Label Utility, Version 1.0 CD. The installation/user guide is entitled "LifeCare PCA Barcode Label

FDA device recall Z-1181-2008 · posted 2008-08-06 · Terminated

Recall details

Recalling firm

Hospira Inc.

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

MEA

Quantity affected

127 CDs

Distribution

Nationwide Distribution and Canada

Date initiated

2008-01-03

Date posted

2008-08-06

Date terminated

2010-03-09

Location

Lake Forest, IL